Hydraulic Cystometric Device Suppliers
Limit companies to: Worldwide USA
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA 
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Bone Densitometer (FDA Code: KGI), Bone Densitometry System, Angled Biopsy Punch, Amniotome (FDA Code: HGE), Assisted Reproduction Devices, ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
Mediwatch USA | Address: 1501 Northpoint Parkway ,Suite 103, West Palm Beach, Florida 33407, USA
www.mediwatch.com | Send Inquiry | Phone: 888-471-2611
Products: Disposable Surface Electrodes, Disks With Leads, Disposable Surface Electrodes, Tab Electrodes, Disposable Pressure Transducers, Digital Ultrasound Imaging System, Portable Multipurpose Real-Time Ultrasound Scanner, Portable Real-Time Bladder Scanner, ...
Mediwatch USA is engaged in developing medical products for the point-of-care environment. We have medical equipment for the diagnosis of a variety of clinical conditions. We expertise in urology, dia more...
www.mediwatch.com | Send Inquiry | Phone: 888-471-2611
Products: Disposable Surface Electrodes, Disks With Leads, Disposable Surface Electrodes, Tab Electrodes, Disposable Pressure Transducers, Digital Ultrasound Imaging System, Portable Multipurpose Real-Time Ultrasound Scanner, Portable Real-Time Bladder Scanner, ...
Mediwatch USA is engaged in developing medical products for the point-of-care environment. We have medical equipment for the diagnosis of a variety of clinical conditions. We expertise in urology, dia more...
Cook Urological | Address: 1100 West Morgan Street,P.O. Box 227, Spencer, Indiana 47460, USA
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Airway Management, ET Tubes, Airway Management, Adult Bronchoscope, Airway Management, Fiber Bronchoscope, Airway Management, Pediatric Bronchoscope, Airway Management, 3 Or Three Way Foley Catheter, ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Life-Tech, Inc. | Address: 4235 Greenbriar Dr., Stafford, Texas 77477-3995, USA
www.Life-Tech.com | Send Inquiry | Phone: +1-(281)-491-6600, (800)-231-9841
Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Nerve Stimulators, Constant Voltage Nerve Stimulators, Peripheral Nerve Stimulators, Electrical Nerve Stimulators, Vagal Nerve Stimulators, Iontophoresis, ...
Life-Tech, Inc. produces electronic medical devices and disposables. We are accredited with ISO 13485 certification. We offer products such as urodynamic systems and consumables, auto read & urodiary more...
www.Life-Tech.com | Send Inquiry | Phone: +1-(281)-491-6600, (800)-231-9841
Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Nerve Stimulators, Constant Voltage Nerve Stimulators, Peripheral Nerve Stimulators, Electrical Nerve Stimulators, Vagal Nerve Stimulators, Iontophoresis, ...
Life-Tech, Inc. produces electronic medical devices and disposables. We are accredited with ISO 13485 certification. We offer products such as urodynamic systems and consumables, auto read & urodiary more...
Wolfe Tory Medical, Inc. | Address: 79 West 4500 South, Suite 18, Salt Lake City, Utah 84107, USA
www.wolfetory.com | Send Inquiry | Phone: 801-281-3000
Products: Tissue Retractors, Intubation Kits, Disposable Irrigating Syringe, Non Dental Irrigating Syringe (FDA Code: KYZ), Topical Anesthesia Applicator (FDA Code: CCT), Tracheal Tube with/without Connector (FDA Code: BTR), ...
Wolfe Tory Medical, Inc. specializes in disposable medical devices designed to improve clinical outcomes and patient comfort. Our product portfolio consists of an intra-abdominal pressure monitoring k more...
www.wolfetory.com | Send Inquiry | Phone: 801-281-3000
Products: Tissue Retractors, Intubation Kits, Disposable Irrigating Syringe, Non Dental Irrigating Syringe (FDA Code: KYZ), Topical Anesthesia Applicator (FDA Code: CCT), Tracheal Tube with/without Connector (FDA Code: BTR), ...
Wolfe Tory Medical, Inc. specializes in disposable medical devices designed to improve clinical outcomes and patient comfort. Our product portfolio consists of an intra-abdominal pressure monitoring k more...
Laborie Medical Technologies | Address: 400 Avenue D, Suite10, Williston, Vermont 05495-7828, USA
www.laborie.com | Send Inquiry | Phone: +1-(802)-857-1300, 800-522-6743
FDA Registration: 9681424 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9000, ISO 9001, CE Certified
Products: Brachytherapy C-Arm Table, Brachytherapy Table Systems, 24 Hour Uroflowmetry System, Air-Charged Catheters, Abdominal Probe Ultrasound System, Anorectal Manometry (ARM) System, ...
Laborie Medical Technologies produces urodynamics equipment. We offer products like urodynamics, pelvi muscle rehabilitation, anorectal manometry, NuWav ultrasound, software, disposables & urodynamic more...
www.laborie.com | Send Inquiry | Phone: +1-(802)-857-1300, 800-522-6743
FDA Registration: 9681424 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9000, ISO 9001, CE Certified
Products: Brachytherapy C-Arm Table, Brachytherapy Table Systems, 24 Hour Uroflowmetry System, Air-Charged Catheters, Abdominal Probe Ultrasound System, Anorectal Manometry (ARM) System, ...
Laborie Medical Technologies produces urodynamics equipment. We offer products like urodynamics, pelvi muscle rehabilitation, anorectal manometry, NuWav ultrasound, software, disposables & urodynamic more...
Verathon Inc. | Address: 20001 North Creek Parkway, Bothell, Washington 98011, USA
www.verathon.com | Send Inquiry | Phone: +1-(425)-867-1348
FDA Registration: 3022472 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, CE Certified
Products: Ultrasound Bladder Scanners, Bladder Volume Instruments, FloPointr Elite Uroflow System, Ultrasonic Scanner, Pediatric Ultrasonic Scanner, Ultrasonic Puls-Echo Scanner (FDA Code: IYO), ...
Verathon Inc. designs, manufactures and distributes medical devices. We use emerging ultrasound technology to develop noninvasive, easy to use medical devices that would fill unmet needs in the health more...
www.verathon.com | Send Inquiry | Phone: +1-(425)-867-1348
FDA Registration: 3022472 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, CE Certified
Products: Ultrasound Bladder Scanners, Bladder Volume Instruments, FloPointr Elite Uroflow System, Ultrasonic Scanner, Pediatric Ultrasonic Scanner, Ultrasonic Puls-Echo Scanner (FDA Code: IYO), ...
Verathon Inc. designs, manufactures and distributes medical devices. We use emerging ultrasound technology to develop noninvasive, easy to use medical devices that would fill unmet needs in the health more...
Alpine Biomed Corp. | Address: 17800 Newhope St., Suite B, Fountain Valley, California 92708-1396, USA
www.alpinebiomed.com | Send Inquiry | Phone: +1-(714)-839-8426, 800-222-0074
Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 13485:2003 Certified
Products: Needle Electrode (FDA Code: GXZ), Diagnostic Spirometer (FDA Code: BZG), Cutaneous Electrode (FDA Code: GXY), Diagnostic Electromyograph Needle Electrode (FDA Code: IKT), Electrical Gastrointestinal Motility Analyzer (FDA Code: FFX), Hydraulic Cystometric Device (FDA Code: FEN), ...
Alpine Biomed Corp. is a designer, manufacturer and distributor of diagnostic equipment & accessories used in gastroenterology & neurology. We offer established Keypoint ® EMG/EP brand and stellat more...
www.alpinebiomed.com | Send Inquiry | Phone: +1-(714)-839-8426, 800-222-0074
Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 13485:2003 Certified
Products: Needle Electrode (FDA Code: GXZ), Diagnostic Spirometer (FDA Code: BZG), Cutaneous Electrode (FDA Code: GXY), Diagnostic Electromyograph Needle Electrode (FDA Code: IKT), Electrical Gastrointestinal Motility Analyzer (FDA Code: FFX), Hydraulic Cystometric Device (FDA Code: FEN), ...
Alpine Biomed Corp. is a designer, manufacturer and distributor of diagnostic equipment & accessories used in gastroenterology & neurology. We offer established Keypoint ® EMG/EP brand and stellat more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Medtronic Neuromodulation | Address: 710 Medtronic Parkway NE, Minneapolis, Minnesota 55459-9896, USA
www.medtronic.com/neuro | Phone: +1-(763)-514-4000
FDA Registration: 3007566237
Products: Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Bipolar Electrode Cables, Electrosurgical Electrode Cables, Product Development, Micro pH Electrodes, Stomach pH Electrode (FDA Code: FFT), ...
Medtronic Neuromodulation provides solutions for people with chronic pain. We specialize in cardiac rhythm disease management, spinal and biologics, cardiovascular, neuromodulation, diabetes & surgica more...
www.medtronic.com/neuro | Phone: +1-(763)-514-4000
FDA Registration: 3007566237
Products: Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Bipolar Electrode Cables, Electrosurgical Electrode Cables, Product Development, Micro pH Electrodes, Stomach pH Electrode (FDA Code: FFT), ...
Medtronic Neuromodulation provides solutions for people with chronic pain. We specialize in cardiac rhythm disease management, spinal and biologics, cardiovascular, neuromodulation, diabetes & surgica more...
Unisensor USA, Inc. | Address: 231 Corporate Drive, Portsmouth, New Hampshire 03801, USA
www.unisensor.ch | Send Inquiry | Phone: +1-(603)-570-2675
FDA Registration: 1226718 Year Established: 1992 Annual Revenues: < USD 1 Million
Products: Catheters, Epidural Catheters, Bladder Pressure Catheter, Diagnostic Biliary Catheter (FDA Code: FGE), Cystometry Catheters, Anorectal Manometry Catheters, ...
Unisensor USA, Inc. manufactures the solid-state-pressure-sensor-catheters used in GI applications, urological applications, intracompartmental pressure & ICP. Our unitip catheter is compatible to all more...
www.unisensor.ch | Send Inquiry | Phone: +1-(603)-570-2675
FDA Registration: 1226718 Year Established: 1992 Annual Revenues: < USD 1 Million
Products: Catheters, Epidural Catheters, Bladder Pressure Catheter, Diagnostic Biliary Catheter (FDA Code: FGE), Cystometry Catheters, Anorectal Manometry Catheters, ...
Unisensor USA, Inc. manufactures the solid-state-pressure-sensor-catheters used in GI applications, urological applications, intracompartmental pressure & ICP. Our unitip catheter is compatible to all more...
Medan Inc. | Address: 131 Nw 4th Street, Suite 395, Corvallis, Oregon 97330, USA
Phone: +1-(541)-231-4141
Products: Urodynamics Systems, Hydraulic Cystometric Device (FDA Code: FEN), ...
Medan Inc. provides hydraulic cystometric & urodynamic devices. more...
Phone: +1-(541)-231-4141
Products: Urodynamics Systems, Hydraulic Cystometric Device (FDA Code: FEN), ...
Medan Inc. provides hydraulic cystometric & urodynamic devices. more...
Degania Silicone, Inc. | Address: 1226 Mendon Road, Cumberland, Rhode Island 2864, USA
Send Inquiry | Phone: +1-(401)-333-8199
FDA Registration: 8030107 Year Established: 1984 Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Foley Catheters, Gastrostomy Feeding Tubes, Silicone Elastomer (FDA Code: MDA), Non-Pneumatic Tourniquet (FDA Code: GAX), Nipple Shield (FDA Code: HFS), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Degania Silicone, Inc. offers products such as forcep covers, color coded silicone tubes, foley catheter, gastrostomy tube, silicone ribbons and sterile feeding bottles. more...
Send Inquiry | Phone: +1-(401)-333-8199
FDA Registration: 8030107 Year Established: 1984 Employee Count: ~220 Quality: ISO 9001, CE Certified
Products: Foley Catheters, Gastrostomy Feeding Tubes, Silicone Elastomer (FDA Code: MDA), Non-Pneumatic Tourniquet (FDA Code: GAX), Nipple Shield (FDA Code: HFS), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
Degania Silicone, Inc. offers products such as forcep covers, color coded silicone tubes, foley catheter, gastrostomy tube, silicone ribbons and sterile feeding bottles. more...
Argon Medical Devices Inc. | Address: 1445 Flat Creek Road, Athens, Texas 75751, USA
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
Myo/kinetic Systems, Inc. | Address: North 84 West 13562 Leon Rd., Menomonee Falls, Wisconsin 53051, USA
Phone: +1-(414)-255-1005
Products: General Medical Equipment, Uroflowmeter (FDA Code: EXY), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Electrical-Powered Muscle Stimulator (FDA Code: IPF), Hydraulic Cystometric Device (FDA Code: FEN), ...
Myo/kinetic Systems, Inc. specializes in the production of medical equipments. We supply therapeutic stimulator and urodynamic equipments. more...
Phone: +1-(414)-255-1005
Products: General Medical Equipment, Uroflowmeter (FDA Code: EXY), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Electrical-Powered Muscle Stimulator (FDA Code: IPF), Hydraulic Cystometric Device (FDA Code: FEN), ...
Myo/kinetic Systems, Inc. specializes in the production of medical equipments. We supply therapeutic stimulator and urodynamic equipments. more...
Mediplus Ltd. | Address: Unit 7 The Gateway Centre, Coronation Rd Cressex Bus. Pk., High Wycombe, Bucks HP12 3SU, United Kingdom 
www.mediplus.co.uk | Send Inquiry | Phone: +44-(1494)-551200
FDA Registration: 9617192 Year Established: 1986 Quality: CE mark, ISO9001 and ISO 13485 Certified
Products: Catheter Accessories (FDA Code: KGZ), Esophageal Motility Monitor and Tube (FDA Code: KLA), Hydraulic Cystometric Device (FDA Code: FEN), ...
Mediplus Ltd. specializes in the research, development, manufacture and marketing of medical devices that meet the needs of patients & clinicians worldwide. The Mediplus code 5100 Ch 4.5 bladder press more...
www.mediplus.co.uk | Send Inquiry | Phone: +44-(1494)-551200
FDA Registration: 9617192 Year Established: 1986 Quality: CE mark, ISO9001 and ISO 13485 Certified
Products: Catheter Accessories (FDA Code: KGZ), Esophageal Motility Monitor and Tube (FDA Code: KLA), Hydraulic Cystometric Device (FDA Code: FEN), ...
Mediplus Ltd. specializes in the research, development, manufacture and marketing of medical devices that meet the needs of patients & clinicians worldwide. The Mediplus code 5100 Ch 4.5 bladder press more...
Albyn Medical Sl | Address: Street D Number 1, Poligono Cordovilla, Cordovilla, ES-NA 31191, Spain
web.smartmedicalgroup.com
Products: Uroflowmeter (FDA Code: EXY), Hydraulic Cystometric Device (FDA Code: FEN), ...
Albyn Medical Sl designs and manufactures equipment & consumables for urology, gynaecology and gastroenterology. We also provide endoscopy accessories, gastric transit markers and urodynamics catheter more...
web.smartmedicalgroup.com
Products: Uroflowmeter (FDA Code: EXY), Hydraulic Cystometric Device (FDA Code: FEN), ...
Albyn Medical Sl designs and manufactures equipment & consumables for urology, gynaecology and gastroenterology. We also provide endoscopy accessories, gastric transit markers and urodynamics catheter more...
Medical Measurement Systems B.V. | Address: Colosseum 25, Enschede 7521 PV, Netherlands
www.mmsonline.nl | Send Inquiry | Phone: +31-(53)-4803700
FDA Registration: 9611896
Products: Evoked Response Electrical Stimulator (FDA Code: GWF), Nerve Conduction Velocity Measurement Device (FDA Code: JXE), Radiological Image Processing System (FDA Code: LLZ), Electrical Gastrointestinal Motility Analyzer (FDA Code: FFX), Electrical Recording Cystometer (FDA Code: EXQ), Hydraulic Cystometric Device (FDA Code: FEN), ...
Medical Measurement Systems B.V. develops, produces and markets medical diagnostic systems for urodynamics, gastroenterology & neurology. We market a complete line of diagnostic equipment, from easy t more...
www.mmsonline.nl | Send Inquiry | Phone: +31-(53)-4803700
FDA Registration: 9611896
Products: Evoked Response Electrical Stimulator (FDA Code: GWF), Nerve Conduction Velocity Measurement Device (FDA Code: JXE), Radiological Image Processing System (FDA Code: LLZ), Electrical Gastrointestinal Motility Analyzer (FDA Code: FFX), Electrical Recording Cystometer (FDA Code: EXQ), Hydraulic Cystometric Device (FDA Code: FEN), ...
Medical Measurement Systems B.V. develops, produces and markets medical diagnostic systems for urodynamics, gastroenterology & neurology. We market a complete line of diagnostic equipment, from easy t more...
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FDA Code / Regulation: FEN / 876.1620
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 876.9.
