Nose Clips Suppliers
Limit companies to: Worldwide USA
Spirometrics | Address: 22 Shaker Rd., P.O. Box 680, Gray, Maine 04039, USA 
www.spirometrics.com | Send Inquiry | Phone: +1-(207)-657-6700, 800-767-0004
Quality: ISO 9001, CE Certified
Products: General Medical Supplies, Spirometry Monitoring Paper, Nose Clips (FDA Code: BXJ), Peak Flow Meters, Peak Flow Measurement, Disposable Filters, ...
Spirometrics is engaged in designing, manufacturing and marketing adult and children's peak flow meter. We offer spirometer accessories for healthcare professionals to treat patients more effectively. more...
www.spirometrics.com | Send Inquiry | Phone: +1-(207)-657-6700, 800-767-0004
Quality: ISO 9001, CE Certified
Products: General Medical Supplies, Spirometry Monitoring Paper, Nose Clips (FDA Code: BXJ), Peak Flow Meters, Peak Flow Measurement, Disposable Filters, ...
Spirometrics is engaged in designing, manufacturing and marketing adult and children's peak flow meter. We offer spirometer accessories for healthcare professionals to treat patients more effectively. more...
Mohawk Medical Mall | Address: 335 Columbia Street, Utica, New York 13502, USA
www.mohawkmedicalmall.com | Send Inquiry | Phone: +1-(315)-797-0570, 800-962-5660
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Anoscopes, Adult Nonrebreathing Mask, Air Cushion Face Masks, Alcohol Prep Pad, Anesthesia Face Masks, Ambulatory Blood Pressure Monitor, ...
Mohawk Medical Mall specializes in offering healthcare supplies and equipment. We offer various medical equipment including anoscopes, blood drawing chairs, cabinets, centrifuges, colposcopes, defibri more...
www.mohawkmedicalmall.com | Send Inquiry | Phone: +1-(315)-797-0570, 800-962-5660
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Anoscopes, Adult Nonrebreathing Mask, Air Cushion Face Masks, Alcohol Prep Pad, Anesthesia Face Masks, Ambulatory Blood Pressure Monitor, ...
Mohawk Medical Mall specializes in offering healthcare supplies and equipment. We offer various medical equipment including anoscopes, blood drawing chairs, cabinets, centrifuges, colposcopes, defibri more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
A-M Systems, Inc. | Address: PO Box 850, Carlsborg, Washington 98324, USA
www.a-msystems.com | Send Inquiry | Phone: +1-(360)-683-8300, 800-426-1306
FDA Registration: 3020614 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: General Medical Supplies, Nebulizers, Spirometer & Respiratory Aids, Alligator Clips, Nasal Cannulas, Peak Flow Meters, ...
A-M Systems, Inc. supplies medical products. Our product categories are pulmonary & respiratory, and physiology & neuroscience. Our pulmunatory and respiratory products comprise of mouthpiece, adapter more...
www.a-msystems.com | Send Inquiry | Phone: +1-(360)-683-8300, 800-426-1306
FDA Registration: 3020614 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: General Medical Supplies, Nebulizers, Spirometer & Respiratory Aids, Alligator Clips, Nasal Cannulas, Peak Flow Meters, ...
A-M Systems, Inc. supplies medical products. Our product categories are pulmonary & respiratory, and physiology & neuroscience. Our pulmunatory and respiratory products comprise of mouthpiece, adapter more...
TIDI Products, LLC | Address: 570 Enterprise Drive, Neenah, Wisconsin 54956, USA
tidiproducts.com | Send Inquiry | Phone: +1-(800)-521-1314
FDA Registration: 2182318
Products: X-Ray Aids, Diagnostic Aids, Adhesive Cloth, Cotton Sponges, Cotton & Rayon Dressings, Cups, ...
TIDI Products, LLC manufactures single-use infection control products for the medical, dental and foodservice markets, and a variety of poly films for converters. We are an ISO 9001:2000, EN/ISO 13485 more...
tidiproducts.com | Send Inquiry | Phone: +1-(800)-521-1314
FDA Registration: 2182318
Products: X-Ray Aids, Diagnostic Aids, Adhesive Cloth, Cotton Sponges, Cotton & Rayon Dressings, Cups, ...
TIDI Products, LLC manufactures single-use infection control products for the medical, dental and foodservice markets, and a variety of poly films for converters. We are an ISO 9001:2000, EN/ISO 13485 more...
American Imex | Address: 16520 Aston Street, Irvine, California 92606, USA
www.americanimex.com | Send Inquiry | Phone: +1-(949)-553-8885/800-521-8286
Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, Certified
Products: Biofeedback & Electrotherapy, Biofeedback Machines, Biofeedback Electrodes, Electrode Belts, Electromedical Adhesive Removers, Electromedical Adhesives, ...
American Imex, provides care devices for reducing pain by facilitating rehabilitation and promoting wellness. We provide electromedical products, behavioral training equipment for incontinence, and re more...
www.americanimex.com | Send Inquiry | Phone: +1-(949)-553-8885/800-521-8286
Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, Certified
Products: Biofeedback & Electrotherapy, Biofeedback Machines, Biofeedback Electrodes, Electrode Belts, Electromedical Adhesive Removers, Electromedical Adhesives, ...
American Imex, provides care devices for reducing pain by facilitating rehabilitation and promoting wellness. We provide electromedical products, behavioral training equipment for incontinence, and re more...
Oemedic International, Inc. | Address: No. 162, Atlantic Street, Pomona, California 91768, USA
Phone: +1-(886)-2-22903959
Products: Massagers, Direct Patient Interface Nebulizer (FDA Code: CAF), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), Operating Room Scrub Brush (FDA Code: GEC), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), ...
Oemedic International, Inc. manufactures manual emergency ventilator and manual therapeutic massager. more...
Phone: +1-(886)-2-22903959
Products: Massagers, Direct Patient Interface Nebulizer (FDA Code: CAF), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), Operating Room Scrub Brush (FDA Code: GEC), Manual Therapeutic Massager (FDA Code: LYG), Powered Heating Pad (FDA Code: IRT), ...
Oemedic International, Inc. manufactures manual emergency ventilator and manual therapeutic massager. more...
Creative Biomedics, Inc. | Address: 924 Calle Negocio, Suite A, San Clemente, California 92673, USA
www.creativebiomedics.com | Send Inquiry | Phone: +1-(949)-366-2300
Year Established: 2000 Annual Revenues: < USD 1 Million
Products: Diagnostic Flow Sensors, Aerosol Therapy Spacers, Environmental Control Filters, Disposable Mouthpieces, Carbon Monoxide Analyzers, Carbon Monoxide Monitors, ...
Creative Biomedics, Inc. produces and distributes medical diagnostic test equipment & disposable products. Our spirometry system is a computer based pulmonary function analyzer, which combines the acc more...
www.creativebiomedics.com | Send Inquiry | Phone: +1-(949)-366-2300
Year Established: 2000 Annual Revenues: < USD 1 Million
Products: Diagnostic Flow Sensors, Aerosol Therapy Spacers, Environmental Control Filters, Disposable Mouthpieces, Carbon Monoxide Analyzers, Carbon Monoxide Monitors, ...
Creative Biomedics, Inc. produces and distributes medical diagnostic test equipment & disposable products. Our spirometry system is a computer based pulmonary function analyzer, which combines the acc more...
Vacumed | Address: 4538 Westinghouse Street, Ventura, California 93003, USA
www.vacumed.com | Send Inquiry | Phone: +1-(805)-805-644-74
FDA Registration: 2023529 Year Established: 1968 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Electrocardiographs (ECGs), Oxygen Aids, Dual Extremity Ergometers, Medical Oxygen, Neonatal Multiparameter Monitors, Oxygen Monitors and Analyzers, ...
Vacumed specializes in medical instrumentation and supplies. We offer adapter, bags, body fat analyzer, calibration gases & regulators, calibration syringes and ECG systems. We also provide gauge save more...
www.vacumed.com | Send Inquiry | Phone: +1-(805)-805-644-74
FDA Registration: 2023529 Year Established: 1968 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Electrocardiographs (ECGs), Oxygen Aids, Dual Extremity Ergometers, Medical Oxygen, Neonatal Multiparameter Monitors, Oxygen Monitors and Analyzers, ...
Vacumed specializes in medical instrumentation and supplies. We offer adapter, bags, body fat analyzer, calibration gases & regulators, calibration syringes and ECG systems. We also provide gauge save more...
nSpire Health, Inc. | Address: 1830 Lefthand Circle, Longmont, Colorado 80501, USA
www.nspirehealth.com | Send Inquiry | Phone: +1-(303)-666-5555, 800-574-7374
FDA Registration: 3006254047 Year Established: 1990 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Spirometers, Cardiopulmonary Stress Testing System, Respirometers, Asthma Management Kit, Peak Flow Meters & MDI Spacers, Universal-Range 50-720 LPM, Aspirators, ...
nSpire Health, Inc. develops and manufactures respiratory care products & provides related services. We focus on cardiopulmonary diagnostics, respiratory core lab services, and disease management solu more...
www.nspirehealth.com | Send Inquiry | Phone: +1-(303)-666-5555, 800-574-7374
FDA Registration: 3006254047 Year Established: 1990 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9002, CE Certified
Products: Spirometers, Cardiopulmonary Stress Testing System, Respirometers, Asthma Management Kit, Peak Flow Meters & MDI Spacers, Universal-Range 50-720 LPM, Aspirators, ...
nSpire Health, Inc. develops and manufactures respiratory care products & provides related services. We focus on cardiopulmonary diagnostics, respiratory core lab services, and disease management solu more...
Mercury Medical | Address: 11300 49th Street North, Clearwater, Florida 33762-4807, USA
www.mercurymed.com | Send Inquiry | Phone: +1-(727)-573-0088, 800-237-6418
FDA Registration: 1024404 Year Established: 1963 Annual Revenues: USD 25-50 Million Employee Count: ~170 Quality: ISO 9001, CE Certified
Products: General Examination Supplies, Airway Pressure Monitors, End-tidal Carbon Dioxide Monitors, Blenders, Expiratory Resistance Kits, Diagnostic Laryngoscopy Equipment, ...
Mercury Medical is a comprehensive health care company specializing in anesthesia, respiratory and critical care products & services. We offer a patented ILA, an improved supralaryngeal airway, where more...
www.mercurymed.com | Send Inquiry | Phone: +1-(727)-573-0088, 800-237-6418
FDA Registration: 1024404 Year Established: 1963 Annual Revenues: USD 25-50 Million Employee Count: ~170 Quality: ISO 9001, CE Certified
Products: General Examination Supplies, Airway Pressure Monitors, End-tidal Carbon Dioxide Monitors, Blenders, Expiratory Resistance Kits, Diagnostic Laryngoscopy Equipment, ...
Mercury Medical is a comprehensive health care company specializing in anesthesia, respiratory and critical care products & services. We offer a patented ILA, an improved supralaryngeal airway, where more...
Sun Med | Address: 12393 Belcher Road Unit 450, Largo, Florida 33773-3097, USA
www.sunmedusa.com | Send Inquiry | Phone: +1-(727)-530-7099, 800-433-2797
FDA Registration: 1036445 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: CPR Equipment, Larynx & Nasopharynx & Rhino, General EMT, Resuscitation, Resuscitation Equipment Kits, Resuscitation Equipment, ...
Sun Med imports and distributes finished medical devices. We are the global supplier of anesthesia, respiratory and urology accessories. We specialize in airway management products. We offer a complet more...
www.sunmedusa.com | Send Inquiry | Phone: +1-(727)-530-7099, 800-433-2797
FDA Registration: 1036445 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: CPR Equipment, Larynx & Nasopharynx & Rhino, General EMT, Resuscitation, Resuscitation Equipment Kits, Resuscitation Equipment, ...
Sun Med imports and distributes finished medical devices. We are the global supplier of anesthesia, respiratory and urology accessories. We specialize in airway management products. We offer a complet more...
Sunmed Healthcare | Address: 12393 Belcher Road, Suite 460, Largo, Florida 33773, USA
www.sunmedhealthcare.com | Send Inquiry | Phone: +1-(727)-531-7266
Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Anesthesia Circuit, Breathing Bags, Adult Laryngoscope Lamp, Breathing Bags, 3-Liter Latex-Free Breathing Bags w/ Hanging Loop, Anesthesia Adapter, Anesthetic Gas Mask (FDA Code: BSJ), ...
Sunmed Healthcare provides anesthesia, respiratory and urology accessories. Our product line includes endotracheal tubes, foley catheters, economy hospital urine bags, leg bags, intubation aids, laryn more...
www.sunmedhealthcare.com | Send Inquiry | Phone: +1-(727)-531-7266
Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Anesthesia Circuit, Breathing Bags, Adult Laryngoscope Lamp, Breathing Bags, 3-Liter Latex-Free Breathing Bags w/ Hanging Loop, Anesthesia Adapter, Anesthetic Gas Mask (FDA Code: BSJ), ...
Sunmed Healthcare provides anesthesia, respiratory and urology accessories. Our product line includes endotracheal tubes, foley catheters, economy hospital urine bags, leg bags, intubation aids, laryn more...
Seven Harvest Intl. Import & Export | Address: 108 North Dixon Rd., Kokomo, Indiana 46901, USA
Phone: +1-(765)-456-3584
Products: Nose Clips (FDA Code: BXJ), Disposable Spiro Nose Clips, Plastic Nose Clip, White Padded Nose Clip, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Seven Harvest Intl. Import & Export offers anesthesiology oropharyngeal airway, nose clips and breathing mouthpieces. more...
Phone: +1-(765)-456-3584
Products: Nose Clips (FDA Code: BXJ), Disposable Spiro Nose Clips, Plastic Nose Clip, White Padded Nose Clip, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Seven Harvest Intl. Import & Export offers anesthesiology oropharyngeal airway, nose clips and breathing mouthpieces. more...
Sunrise Medical International Inc. | Address: 4106 Ryan Court, Kokomo, Indiana 46902, USA
Phone: +1-(410)-740-0169
FDA Registration: 3007494890
Products: Nose Clips (FDA Code: BXJ), Extension Airway Connector (FDA Code: BZA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Pressure Tubing and Accessories (FDA Code: BYX), Medical Gas Yoke Assembly (FDA Code: CAM), Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX), ...
Sunrise Medical International Inc. deals with anesthesiology oropharyngeal airways, extension airway connectors and medical gas yoke assemblies. We also provide nose clips, pressure tubings & accessor more...
Phone: +1-(410)-740-0169
FDA Registration: 3007494890
Products: Nose Clips (FDA Code: BXJ), Extension Airway Connector (FDA Code: BZA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Pressure Tubing and Accessories (FDA Code: BYX), Medical Gas Yoke Assembly (FDA Code: CAM), Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX), ...
Sunrise Medical International Inc. deals with anesthesiology oropharyngeal airways, extension airway connectors and medical gas yoke assemblies. We also provide nose clips, pressure tubings & accessor more...
Hans Rudolph Inc | Address: 8325 Cole Parkway, Shawnee, Kansas 66227, USA
www.rudolphkc.com | Send Inquiry | Phone: +1-(913)-422-7788/800-456-6695
FDA Registration: 1922553
Products: Calibration Equipment, CPAP Masks, Airflow Pressure Transducers, CPAP Therapy Accessories, CPAP Nasal Systems, Calibration Syringe, ...
Hans Rudolph, inc. is a designer and manufacturer of respiratory valves and other respiratory products. Our products include breathing valves, non-diffusing gas bags, nose clips, mouthpieces, respirat more...
www.rudolphkc.com | Send Inquiry | Phone: +1-(913)-422-7788/800-456-6695
FDA Registration: 1922553
Products: Calibration Equipment, CPAP Masks, Airflow Pressure Transducers, CPAP Therapy Accessories, CPAP Nasal Systems, Calibration Syringe, ...
Hans Rudolph, inc. is a designer and manufacturer of respiratory valves and other respiratory products. Our products include breathing valves, non-diffusing gas bags, nose clips, mouthpieces, respirat more...
SDI Diagnostics | Address: Ten Hampden Drive, Easton, Massachusetts 02375, USA
www.sdidiagnostics.com | Send Inquiry | Phone: +1-(800)-678-5782, (508)-238-7033
FDA Registration: 1220253 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: Spirometers, Forceps (FDA Code: HTD), General Diagnostic Supplies, General Medical Supplies, Nebulizers, Aspirators, ...
SDI Diagnostics provides products for respiratory care. We are a spirometry source. Our Astra200 Spirometer is a multi-functional spirometry designed to provide a whole new level of sophistication to more...
www.sdidiagnostics.com | Send Inquiry | Phone: +1-(800)-678-5782, (508)-238-7033
FDA Registration: 1220253 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: Spirometers, Forceps (FDA Code: HTD), General Diagnostic Supplies, General Medical Supplies, Nebulizers, Aspirators, ...
SDI Diagnostics provides products for respiratory care. We are a spirometry source. Our Astra200 Spirometer is a multi-functional spirometry designed to provide a whole new level of sophistication to more...
Allied Healthcare Products Inc | Address: 1720 Sublette Avenue, St. Louis, Missouri 63110, USA
www.alliedhpi.com | Send Inquiry | Phone: +1-(800)-444-3954
FDA Registration: 1314798 Year Established: 1958 Annual Revenues: USD 5-10 Million Employee Count: ~900 Quality: CE Certified
Products: Splints, Curettes, Forceps (FDA Code: HTD), Instrument Stands, Anesthesia, Aspirators, ...
Allied Healthcare Products Inc manufactures medical gas construction equipment, respiratory therapy equipment, home health care products and emergency medical equipment. We develop a broad range of pr more...
www.alliedhpi.com | Send Inquiry | Phone: +1-(800)-444-3954
FDA Registration: 1314798 Year Established: 1958 Annual Revenues: USD 5-10 Million Employee Count: ~900 Quality: CE Certified
Products: Splints, Curettes, Forceps (FDA Code: HTD), Instrument Stands, Anesthesia, Aspirators, ...
Allied Healthcare Products Inc manufactures medical gas construction equipment, respiratory therapy equipment, home health care products and emergency medical equipment. We develop a broad range of pr more...
Instrumentation Industries Inc. | Address: 2990 Industrial Boulevard, Bethel Park, Pennsylvania 15102, USA
iiirespiratory.com | Send Inquiry | Phone: +1-(412)-854-1133
FDA Registration: 2518436 Year Established: 1967 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9003 Certified
Products: 1-Liter Latex-Free Breathing Bag w/ Hanging Loop, 2-Liter Latex-Free Breathing Bags w/ Hanging Loop, 3-Liter Latex-Free Breathing Bags w/ Hanging Loop, 2-Liter Latex-Free Breathing Bag, 1-Liter Latex-Free Breathing Bag, 3-Liter Latex-Free Breathing Bag, ...
Instrumentation Industries Inc. deals in plastic, silicone and metal products for use in the medical industry. We distribute adapters, connectors, valves, gauge/monitors and jet ventilators. We produc more...
iiirespiratory.com | Send Inquiry | Phone: +1-(412)-854-1133
FDA Registration: 2518436 Year Established: 1967 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9003 Certified
Products: 1-Liter Latex-Free Breathing Bag w/ Hanging Loop, 2-Liter Latex-Free Breathing Bags w/ Hanging Loop, 3-Liter Latex-Free Breathing Bags w/ Hanging Loop, 2-Liter Latex-Free Breathing Bag, 1-Liter Latex-Free Breathing Bag, 3-Liter Latex-Free Breathing Bag, ...
Instrumentation Industries Inc. deals in plastic, silicone and metal products for use in the medical industry. We distribute adapters, connectors, valves, gauge/monitors and jet ventilators. We produc more...
Amici, Inc. | Address: 518 Vincent St., Spring City, Pennsylvania 19475-1621, USA
www.amici-inc.com | Send Inquiry | Phone: +1-(610)-948-7100
FDA Registration: 2522920 Year Established: 1978 Annual Revenues: < USD 1 Million Quality: IS0 9001, CE Certified
Products: Air Cushion Masks, Mask Harnesses, Aerosol Delivery System, Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Direct Patient Interface Nebulizer (FDA Code: CAF), Contract Manufacturing, ...
Amici, Inc. is a manufacturer of nuclear lung ventilation products. We produce and distribute diagnostic & therapeutic products for lung ventilation, including masks, mouthpieces, bacteria/virus filte more...
www.amici-inc.com | Send Inquiry | Phone: +1-(610)-948-7100
FDA Registration: 2522920 Year Established: 1978 Annual Revenues: < USD 1 Million Quality: IS0 9001, CE Certified
Products: Air Cushion Masks, Mask Harnesses, Aerosol Delivery System, Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Direct Patient Interface Nebulizer (FDA Code: CAF), Contract Manufacturing, ...
Amici, Inc. is a manufacturer of nuclear lung ventilation products. We produce and distribute diagnostic & therapeutic products for lung ventilation, including masks, mouthpieces, bacteria/virus filte more...
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FDA Code / Regulation: BXJ / 868.6225
A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
