Manual Non Powered Refractor with Phoropter Suppliers
Limit companies to: Worldwide USA
Carl Zeiss Meditec, Inc. | Address: 5160 Hacienda Dr, Dublin, California 94568, USA 
www.meditec.zeiss.com | Send Inquiry | Phone: +49 (3641) 6420 30
FDA Registration: 2918630 Year Established: 2000 Annual Revenues: < USD 1 Million Employee Count: ~2100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Keratometers, 35mm Fundus Photography, Automatic Lensmeters, Indocyanine Green Angiography, Fluorescein Angiography, Nd:YAG Laser Capsulotomy Systems, ...
Carl Zeiss Meditec, Inc. supplies complete system solutions in the field of medical technology for ophthalmology. We offer a full complement of synergistic technologies for the detection & quantifiabl more...
www.meditec.zeiss.com | Send Inquiry | Phone: +49 (3641) 6420 30
FDA Registration: 2918630 Year Established: 2000 Annual Revenues: < USD 1 Million Employee Count: ~2100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Keratometers, 35mm Fundus Photography, Automatic Lensmeters, Indocyanine Green Angiography, Fluorescein Angiography, Nd:YAG Laser Capsulotomy Systems, ...
Carl Zeiss Meditec, Inc. supplies complete system solutions in the field of medical technology for ophthalmology. We offer a full complement of synergistic technologies for the detection & quantifiabl more...
Marco | Address: 11825 Central Parkway, Jacksonville, Florida 32224, USA
www.marcooph.com | Send Inquiry | Phone: +1-(904)-642-9330
FDA Registration: 1041845 Year Established: 1962 Annual Revenues: USD 25-50 Million Employee Count: ~40
Products: Keratometers, Exam Chairs, Automatic Lensmeters, Potential Vision Testing, Manual Lensmeters, Manual Refractors, ...
Marco delivers a complete range of vision diagnostic equipment to eye-care practitioners. Our products include refraction systems, wavefront aberrometry, auto refractors, corneal topography, auto lens more...
www.marcooph.com | Send Inquiry | Phone: +1-(904)-642-9330
FDA Registration: 1041845 Year Established: 1962 Annual Revenues: USD 25-50 Million Employee Count: ~40
Products: Keratometers, Exam Chairs, Automatic Lensmeters, Potential Vision Testing, Manual Lensmeters, Manual Refractors, ...
Marco delivers a complete range of vision diagnostic equipment to eye-care practitioners. Our products include refraction systems, wavefront aberrometry, auto refractors, corneal topography, auto lens more...
Optimetrics, Inc. | Address: 6908 N.W. 72 nd Ave, Miami, Florida 33166, USA
www.optimetrics.com | Send Inquiry | Phone: +1-(305)-863-4144
FDA Registration: 1038753
Products: Keratometers, Hand-held Autorefractors, Portable Autorefractors, Lensmeters Keratometers, Automatic Hand-held Keratometers, Human Eye Model, ...
Optimetrics, Inc. provides quality, new & used ophthalmic equipment, & supplies it to ophthalmologists, optometrists, and optical retailers. Our showroom displays a variety of products ranging from a more...
www.optimetrics.com | Send Inquiry | Phone: +1-(305)-863-4144
FDA Registration: 1038753
Products: Keratometers, Hand-held Autorefractors, Portable Autorefractors, Lensmeters Keratometers, Automatic Hand-held Keratometers, Human Eye Model, ...
Optimetrics, Inc. provides quality, new & used ophthalmic equipment, & supplies it to ophthalmologists, optometrists, and optical retailers. Our showroom displays a variety of products ranging from a more...
Woodlyn | Address: 2920 Malmo Drive, Arlington Heights, Illinois 60005, USA
woodlynintl.com | Send Inquiry | Phone: +1-(847)-952-8330
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Manual Lensmeters, Manual Refractors, Biomicroscopic Slit Lamps, Operating Microscopes, Eye Examination Devices and Equipment, Biomicroscopic Slit Lamps, Glasses and Accessories, Manual Refractors, ...
Woodlyn provides ophthalmic instruments and equipment. Our products include examination chairs, millennium instrument stand, slit lamps, digital slit lamp camera, ultravision visual acity tester, clas more...
woodlynintl.com | Send Inquiry | Phone: +1-(847)-952-8330
Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Manual Lensmeters, Manual Refractors, Biomicroscopic Slit Lamps, Operating Microscopes, Eye Examination Devices and Equipment, Biomicroscopic Slit Lamps, Glasses and Accessories, Manual Refractors, ...
Woodlyn provides ophthalmic instruments and equipment. Our products include examination chairs, millennium instrument stand, slit lamps, digital slit lamp camera, ultravision visual acity tester, clas more...
R H Burton Company | Address: 3965 Brookham Drive, Grove City, Ohio 43123, USA
www.rhburton.com | Send Inquiry | Phone: +1-(800)-848-0410
Year Established: 1947 Annual Revenues: USD 10-25 Million Quality: ISO 9001, ISO 9002 Certified
Products: Keratometers, Exam Chairs, Manual Lensmeters, Manual Refractors, Trial Lenses, Automatic Objective Refractors With Visual Acuity, ...
R H Burton Company delivers solutions for professionals in ophthalmology and provides optometry superior instruments & service solutions. We purchase examination equipment online, as well as any bulb more...
www.rhburton.com | Send Inquiry | Phone: +1-(800)-848-0410
Year Established: 1947 Annual Revenues: USD 10-25 Million Quality: ISO 9001, ISO 9002 Certified
Products: Keratometers, Exam Chairs, Manual Lensmeters, Manual Refractors, Trial Lenses, Automatic Objective Refractors With Visual Acuity, ...
R H Burton Company delivers solutions for professionals in ophthalmology and provides optometry superior instruments & service solutions. We purchase examination equipment online, as well as any bulb more...
Right Medical Products | Address: 5325 Cleveland Street Suite 303, Virginia Beach, Virginia 23462, USA
www.rightmedical.com | Send Inquiry | Phone: +1-(757)-963-7064, 888-224-6012
FDA Registration: 3004441848
Products: Keratometers, Automatic Objective Refractors With Visual Acuity, Remote Controlled Conventional Refractors, Chart Projectors, Hand-held Autorefractors, Corneal Topography Keratometers, ...
Right Medical Products supply retinomax K-Plus 2, speedy K, NP-3S chart projector and auto optester remote vision. Our Retinomax K-Plus 2 battery operation eliminates the limitation of being plugged i more...
www.rightmedical.com | Send Inquiry | Phone: +1-(757)-963-7064, 888-224-6012
FDA Registration: 3004441848
Products: Keratometers, Automatic Objective Refractors With Visual Acuity, Remote Controlled Conventional Refractors, Chart Projectors, Hand-held Autorefractors, Corneal Topography Keratometers, ...
Right Medical Products supply retinomax K-Plus 2, speedy K, NP-3S chart projector and auto optester remote vision. Our Retinomax K-Plus 2 battery operation eliminates the limitation of being plugged i more...
Progressive Orthodontics | Address: 135 Columbia, Suite 101, Aliso Viejo, California 92656, USA
www.posortho.com | Send Inquiry | Phone: +1-(714)-973-2266, 800-443-3106
Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Cheek Retractors, Durable Product Contract Manufacturing, Manual Non Powered Refractor with Phoropter (FDA Code: HKN), Micrp Bone Plates, Millimeter Rulers, Headgear Modules, ...
Progressive Orthodontics specializes in offering orthodontic products. Our products include cements & adhesives, diagnostic materials, headgear, patient elastics, separators, instruments, skeletal anc more...
www.posortho.com | Send Inquiry | Phone: +1-(714)-973-2266, 800-443-3106
Year Established: 1980 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Cheek Retractors, Durable Product Contract Manufacturing, Manual Non Powered Refractor with Phoropter (FDA Code: HKN), Micrp Bone Plates, Millimeter Rulers, Headgear Modules, ...
Progressive Orthodontics specializes in offering orthodontic products. Our products include cements & adhesives, diagnostic materials, headgear, patient elastics, separators, instruments, skeletal anc more...
Pacific Ophthalmic Supply | Address: 1924 Oak Knoll Dr., Belmont, California 94002, USA
www.pacific-ophthalmic.com | Send Inquiry | Phone: +1-(650)-637-9391
FDA Registration: 2952604
Products: Slit Lamps, Portable Slit Lamp, AC-Powered Lens Measurment Instrument (FDA Code: HLM), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), Slit Lamp Accessories, ...
Pacific Ophthalmic Supply specializes in supplying new and used ophthalmic equipment. Our products include slit lamps, trail lens set, perimeter trail set, diagnostic lenses and operating loupes. The more...
www.pacific-ophthalmic.com | Send Inquiry | Phone: +1-(650)-637-9391
FDA Registration: 2952604
Products: Slit Lamps, Portable Slit Lamp, AC-Powered Lens Measurment Instrument (FDA Code: HLM), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), Slit Lamp Accessories, ...
Pacific Ophthalmic Supply specializes in supplying new and used ophthalmic equipment. Our products include slit lamps, trail lens set, perimeter trail set, diagnostic lenses and operating loupes. The more...
Hortron Enterprise, Inc. | Address: 1485, Andrew Drive, # G, Claremont, California 91711, USA
www.hortron.com | Send Inquiry | Phone: +1-(909)-621-2628
FDA Registration: 1937579
Products: Keratometers, Lensmeters, Auto Refractor, Lens Driller, Maddox Lens (FDA Code: HKR), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), ...
Hortron Enterprise, Inc. is a manufacturer of optical products. Our product line includes invisible finished lenses, tri-focal semi-finished lenses, bifocal flat top finished lenses and progressive se more...
www.hortron.com | Send Inquiry | Phone: +1-(909)-621-2628
FDA Registration: 1937579
Products: Keratometers, Lensmeters, Auto Refractor, Lens Driller, Maddox Lens (FDA Code: HKR), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), ...
Hortron Enterprise, Inc. is a manufacturer of optical products. Our product line includes invisible finished lenses, tri-focal semi-finished lenses, bifocal flat top finished lenses and progressive se more...
Nidek, Inc. | Address: 47651 Westinghouse Dr., Fremont, California 94539, USA
usa.nidek.com | Phone: +1-(510)-226-5700, 800-223-9044
FDA Registration: 2936921
Products: AC- powered Corneal Topographers (FDA Code: MMQ), AC-Powered Ophthalmic Camera (FDA Code: HKI), AC-Powered Automatic Perimeter (FDA Code: HPT), AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Keratome (FDA Code: HNO), AC-Powered Keratoscope (FDA Code: HLQ), ...
Nidek, Inc. offers a wide array of equipment designed for the diagnosis and treatment of retinal diseases, glaucoma, and other vision-impairing afflictions. Our compact and reliable GYC-1000, solid-st more...
usa.nidek.com | Phone: +1-(510)-226-5700, 800-223-9044
FDA Registration: 2936921
Products: AC- powered Corneal Topographers (FDA Code: MMQ), AC-Powered Ophthalmic Camera (FDA Code: HKI), AC-Powered Automatic Perimeter (FDA Code: HPT), AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Keratome (FDA Code: HNO), AC-Powered Keratoscope (FDA Code: HLQ), ...
Nidek, Inc. offers a wide array of equipment designed for the diagnosis and treatment of retinal diseases, glaucoma, and other vision-impairing afflictions. Our compact and reliable GYC-1000, solid-st more...
U.S. Ophthalmic Llc | Address: 9990 Nw 14 St Unit 105, Doral, Florida 33172, USA
www.usophthalmic.com | Send Inquiry | Phone: +1-(786)-6210521
FDA Registration: 3003595397
Products: Trial Lenses, Patternless Lens Edger, Trial Lenses and Accessories, Auto Refractor, Trial Lens Set, Ophthalmic Refractometer (FDA Code: HKO), ...
U.S. Ophthalmic Llc deals with diagnostic instruments. Our products include auto refractors, patternless edges, trial lens sets and laboratory equipments. We provide refraction units, keratometers, sl more...
www.usophthalmic.com | Send Inquiry | Phone: +1-(786)-6210521
FDA Registration: 3003595397
Products: Trial Lenses, Patternless Lens Edger, Trial Lenses and Accessories, Auto Refractor, Trial Lens Set, Ophthalmic Refractometer (FDA Code: HKO), ...
U.S. Ophthalmic Llc deals with diagnostic instruments. Our products include auto refractors, patternless edges, trial lens sets and laboratory equipments. We provide refraction units, keratometers, sl more...
Mercoframes Optical Corp. | Address: 5555 Nw 74th Ave., Doral, Florida 33166, USA
www.mercoframes.com | Send Inquiry | Phone: +1-(305)-882-0120
FDA Registration: 1064151
Products: Automatic Lensmeters, Digital Pupilometer, Magnifying Spectacle (FDA Code: HOI), Manual Pupillometer (FDA Code: HLH), Non-Custom Prescription Spectacle Lens (FDA Code: HQG), Non Prescription Sunglasses (FDA Code: HQY), ...
Mercoframes Optical Corp. is engaged in the production of optical frames, sunglasses, optical equipment & accessories, laboratory equipment and diagnostic equipment. We offer powered keratoscopes, len more...
www.mercoframes.com | Send Inquiry | Phone: +1-(305)-882-0120
FDA Registration: 1064151
Products: Automatic Lensmeters, Digital Pupilometer, Magnifying Spectacle (FDA Code: HOI), Manual Pupillometer (FDA Code: HLH), Non-Custom Prescription Spectacle Lens (FDA Code: HQG), Non Prescription Sunglasses (FDA Code: HQY), ...
Mercoframes Optical Corp. is engaged in the production of optical frames, sunglasses, optical equipment & accessories, laboratory equipment and diagnostic equipment. We offer powered keratoscopes, len more...
Unicos USA | Address: 8380 NW 64 St., Miami, Florida 33166, USA
www.unicosusa.com | Send Inquiry | Phone: +1-(305)-406-3915
FDA Registration: 3007603859
Products: AC-Powered Medical Examination Device (FDA Code: KZF), AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Lens Measurment Instrument (FDA Code: HLM), AC-Powered Ophthalmic Chair (FDA Code: HME), AC-Powered Pupillometer (FDA Code: HLG), Auto Kerato Refractometers, ...
Unicos USA provides medical practice equipments for ophthalmologists, optometrists and opticians. Our products include auto kerato refractometers, lensmeters, trial lens sets & diagnostic products, la more...
www.unicosusa.com | Send Inquiry | Phone: +1-(305)-406-3915
FDA Registration: 3007603859
Products: AC-Powered Medical Examination Device (FDA Code: KZF), AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Lens Measurment Instrument (FDA Code: HLM), AC-Powered Ophthalmic Chair (FDA Code: HME), AC-Powered Pupillometer (FDA Code: HLG), Auto Kerato Refractometers, ...
Unicos USA provides medical practice equipments for ophthalmologists, optometrists and opticians. Our products include auto kerato refractometers, lensmeters, trial lens sets & diagnostic products, la more...
Arno Optical Corporation | Address: 5402 Nw 72nd Avenue, Miami, Florida 33166, USA
www.arnooptical.com | Send Inquiry | Phone: +1-(757)-2240177
Products: Trial Lenses, Ultrasonic Cleaners, Ophthalmic Lenses, Ophthalmic Trial Lens Clip (FDA Code: HPB), Spectacle (Prescription) Lens For Reading Discomfort (FDA Code: NJH), Contact Lens For Reading Discomfort (FDA Code: NIC), ...
Arno Optical Corporation supplies ophthalmic lenses & various medical accessories. Our products include edgers, blockers, pattern makers, tinting products, ultrasonic cleaners, UV testers and various more...
www.arnooptical.com | Send Inquiry | Phone: +1-(757)-2240177
Products: Trial Lenses, Ultrasonic Cleaners, Ophthalmic Lenses, Ophthalmic Trial Lens Clip (FDA Code: HPB), Spectacle (Prescription) Lens For Reading Discomfort (FDA Code: NJH), Contact Lens For Reading Discomfort (FDA Code: NIC), ...
Arno Optical Corporation supplies ophthalmic lenses & various medical accessories. Our products include edgers, blockers, pattern makers, tinting products, ultrasonic cleaners, UV testers and various more...
Reichert Opthamic Instruments | Address: 3362 Walden Avenue, Depew, New York 14043, USA
www.reichert.com | Send Inquiry | Phone: +1-(716)-686-4500, 888-849-8955
FDA Registration: 1319721 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9000, ISO 9001, CE Certified
Products: Keratometers, Tonometers, Trial Frames, Trial Lenses, Pachymeter, Auto Tonometers, ...
Reichert Opthamic Instruments specializes in opthamic instruments. Our product list comprises of tonometers, pachymeters, slit lamps, refractors & keratometers and lensmeters. Our CT100 tonometer moun more...
www.reichert.com | Send Inquiry | Phone: +1-(716)-686-4500, 888-849-8955
FDA Registration: 1319721 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9000, ISO 9001, CE Certified
Products: Keratometers, Tonometers, Trial Frames, Trial Lenses, Pachymeter, Auto Tonometers, ...
Reichert Opthamic Instruments specializes in opthamic instruments. Our product list comprises of tonometers, pachymeters, slit lamps, refractors & keratometers and lensmeters. Our CT100 tonometer moun more...
Reliance Medical Products | Address: 3535 Kings Mills Rd., Mason, Ohio 45040-2303, USA
www.reliance-medical.com | Phone: +1-(800)-787-5426
FDA Registration: 1523545 Year Established: 1898 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9000, CE Certified
Products: Ophthalmic Instrument Stand (FDA Code: HMG), ENT Treatment Cabinet, Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Adjustable Operating Room Stool (FDA Code: FZM), Bedside Stool, Examination and Treatment Chair (FDA Code: FRK), ...
Reliance Medical Products offers health care products such as exam chairs, exam stools, instrument delivery systems, treatment cabinets, and room light system. Our FX 620 is a full power tilt examinat more...
www.reliance-medical.com | Phone: +1-(800)-787-5426
FDA Registration: 1523545 Year Established: 1898 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9000, CE Certified
Products: Ophthalmic Instrument Stand (FDA Code: HMG), ENT Treatment Cabinet, Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Adjustable Operating Room Stool (FDA Code: FZM), Bedside Stool, Examination and Treatment Chair (FDA Code: FRK), ...
Reliance Medical Products offers health care products such as exam chairs, exam stools, instrument delivery systems, treatment cabinets, and room light system. Our FX 620 is a full power tilt examinat more...
Keeler Ltd. | Address: Clewer Hill Road, Windsor SL4 4AA, United Kingdom 
www.keeler.co.uk | Send Inquiry | Phone: +44-(1753)-85-7177
FDA Registration: 1000391004
Products: Ophthalmoscopes, Ophthalmoscope Aids, Ophthalmoscope Diagnostic Device Aids, Ophthalmoscope Pocket Set, Standard Direct Ophthalmoscopes, Standard Ophthalmoscope, ...
Keeler Ltd. specializes in magnification and diagnostic products for professionals in the optical & healthcare industries. Our product list comprises of direct ophthalmoscopes, volk lenses, otoscopes, more...
www.keeler.co.uk | Send Inquiry | Phone: +44-(1753)-85-7177
FDA Registration: 1000391004
Products: Ophthalmoscopes, Ophthalmoscope Aids, Ophthalmoscope Diagnostic Device Aids, Ophthalmoscope Pocket Set, Standard Direct Ophthalmoscopes, Standard Ophthalmoscope, ...
Keeler Ltd. specializes in magnification and diagnostic products for professionals in the optical & healthcare industries. Our product list comprises of direct ophthalmoscopes, volk lenses, otoscopes, more...
Bobes S.A. | Address: Carretera Fuente Del Toro S/n, El Molar 28710, Spain
Phone: +34-(91)-8412069
Products: AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Ophthalmic Chair (FDA Code: HME), Battery-Operated Operating Headlamp (FDA Code: HPP), Corneal Radius Measurement Instrument (FDA Code: HJB), Manual Tonometer (FDA Code: HKY), Ophthalmic AC-Powered Instrument Stand (FDA Code: HMF), ...
Bobes S.A offers javal trial lens set, chair, stand, slit lamp, keratometer and tonometer. more...
Phone: +34-(91)-8412069
Products: AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO), AC-Powered Ophthalmic Chair (FDA Code: HME), Battery-Operated Operating Headlamp (FDA Code: HPP), Corneal Radius Measurement Instrument (FDA Code: HJB), Manual Tonometer (FDA Code: HKY), Ophthalmic AC-Powered Instrument Stand (FDA Code: HMF), ...
Bobes S.A offers javal trial lens set, chair, stand, slit lamp, keratometer and tonometer. more...
Unicos Co., Ltd. | Address: Unicos Center, 114-1, Munhwa-Dong, Jung-Gu, Daejeon 301-130, Korea, Republic Of 
www.e-unicos.com | Phone: +82-(42)-5810047
FDA Registration: 3004167900
Products: Chart Projectors, Automated Chart Projector, Healthcare Service, Auto Refractor, Auto Refractor Keratometers, Auto Refkeratometer, ...
Unicos Co., Ltd. manufactures healthcare products. We offer ophthalmic instruments, refractors and chart projectors. Our products include karatomaters, digitalize refractors, auto visual acuity tester more...
www.e-unicos.com | Phone: +82-(42)-5810047
FDA Registration: 3004167900
Products: Chart Projectors, Automated Chart Projector, Healthcare Service, Auto Refractor, Auto Refractor Keratometers, Auto Refkeratometer, ...
Unicos Co., Ltd. manufactures healthcare products. We offer ophthalmic instruments, refractors and chart projectors. Our products include karatomaters, digitalize refractors, auto visual acuity tester more...
Potec Co., Ltd. | Address: 292-4 Samseong-Dong, Dong-Gu, Daejeon 300-812, Korea, Republic Of
Phone: +82-(42)-6323536
FDA Registration: 3003984265
Products: Auto Refractor, Computerized Refractor, AC-Powered Lens Measurment Instrument (FDA Code: HLM), Ophthalmic Projector (FDA Code: HOS), Ophthalmic Refractometer (FDA Code: HKO), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), ...
Potec Co., Ltd. deals with instruments, measuring lens and AC-powered devices. Our products include glasses and optics. We provide ophthalmic refractometer, AC-powered lens measurement instruments, ma more...
Phone: +82-(42)-6323536
FDA Registration: 3003984265
Products: Auto Refractor, Computerized Refractor, AC-Powered Lens Measurment Instrument (FDA Code: HLM), Ophthalmic Projector (FDA Code: HOS), Ophthalmic Refractometer (FDA Code: HKO), Manual Non Powered Refractor with Phoropter (FDA Code: HKN), ...
Potec Co., Ltd. deals with instruments, measuring lens and AC-powered devices. Our products include glasses and optics. We provide ophthalmic refractometer, AC-powered lens measurement instruments, ma more...
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FDA Code / Regulation: HKN / 886.1770
A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
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 886.9. 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.
