Color Vision Tester Suppliers
Limit companies to: Worldwide USA
Precision Vision, Ltd. | Address: 1490 S. Yampa Way, Aurora, Colorado 80017, USA 
www.precisionvision.com | Send Inquiry | Phone: +1-(303)-743-0494, 800-843-5367
FDA Registration: 3003846146
Products: Bagolini Lenses (FDA Code: HPD), Bandage Contact Lenses, Visual Acuity Charts (FDA Code: HOX), Bagolini's Striated Lenses, Bandage Soft Contact Lenses, Vision Testing, ETDRS Visual Acuity Charts, ...
Precision Vision, Ltd. is a full service custom GP laboratory specializing in all aspects of gas permeable lens design and fittings. We are an authorized manufacturer for polymer technology, paragon v more...
www.precisionvision.com | Send Inquiry | Phone: +1-(303)-743-0494, 800-843-5367
FDA Registration: 3003846146
Products: Bagolini Lenses (FDA Code: HPD), Bandage Contact Lenses, Visual Acuity Charts (FDA Code: HOX), Bagolini's Striated Lenses, Bandage Soft Contact Lenses, Vision Testing, ETDRS Visual Acuity Charts, ...
Precision Vision, Ltd. is a full service custom GP laboratory specializing in all aspects of gas permeable lens design and fittings. We are an authorized manufacturer for polymer technology, paragon v more...
Stereo Optical Co., Inc. | Address: 8623 W. Bryn Mawr Ave., Suite 502, Chicago, Illinois 60631, USA
www.stereooptical.com | Send Inquiry | Phone: +1-(773)-867-0380, 800-344-9500
FDA Registration: 1419226 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Vision Testers, Near Visual Acuity Charts, Glare Testing, Stereoscopic Vision and Depth Perception Testing, Projector Slides, Vectographic Slides, ...
Stereo Optical Co., Inc. manufactures vision-testing equipment. Our range of equipment includes Optec vision testers, projector slides, stereotests, vectograms, teller cards and contrast sensitivity. more...
www.stereooptical.com | Send Inquiry | Phone: +1-(773)-867-0380, 800-344-9500
FDA Registration: 1419226 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Vision Testers, Near Visual Acuity Charts, Glare Testing, Stereoscopic Vision and Depth Perception Testing, Projector Slides, Vectographic Slides, ...
Stereo Optical Co., Inc. manufactures vision-testing equipment. Our range of equipment includes Optec vision testers, projector slides, stereotests, vectograms, teller cards and contrast sensitivity. more...
Bernell VTP | Address: 4016 N Home St, Mishawaka, Indiana 46545, USA
www.bernell.com | Send Inquiry | Phone: +1-(574)-259-2070
FDA Registration: 1820463 Year Established: 1954 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Pictures, Worth 4 Dot Tests, Tumbling E, Near Visual Acuity Charts, Muscle Lights, Vision Testing, Near Visual Acuity Charts, ...
Bernell VTP distributes ophthalmic products . Our products include contact lens items, eye movement, recorders, low vision, optical, primary, reference material, and vision therapy products. Our eye m more...
www.bernell.com | Send Inquiry | Phone: +1-(574)-259-2070
FDA Registration: 1820463 Year Established: 1954 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Pictures, Worth 4 Dot Tests, Tumbling E, Near Visual Acuity Charts, Muscle Lights, Vision Testing, Near Visual Acuity Charts, ...
Bernell VTP distributes ophthalmic products . Our products include contact lens items, eye movement, recorders, low vision, optical, primary, reference material, and vision therapy products. Our eye m more...
LKC Technologies, Inc. | Address: 2 Professional Drive, Suite 222, Gaithersburg, Maryland 20879, USA
www.lkc.com | Send Inquiry | Phone: +1-(301)-840-1992
FDA Registration: 1119189 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Visual Evoked Potentials, Visual Acuity Systems, Visual Testing Systems, Biomedical Amplifiers, Universal Biomedical Amplifier, Biomedical Amplifiers, Integrated Circuits, ...
LKC Technologies, Inc. specializes in the visual electrophysiology field. We are an ISO 9001 & OTHER CE MARK certified company. Our products are used to diagnose a large number of ophthalmic condition more...
www.lkc.com | Send Inquiry | Phone: +1-(301)-840-1992
FDA Registration: 1119189 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Visual Evoked Potentials, Visual Acuity Systems, Visual Testing Systems, Biomedical Amplifiers, Universal Biomedical Amplifier, Biomedical Amplifiers, Integrated Circuits, ...
LKC Technologies, Inc. specializes in the visual electrophysiology field. We are an ISO 9001 & OTHER CE MARK certified company. Our products are used to diagnose a large number of ophthalmic condition more...
Richmond Products, Inc. | Address: 4400 Silver Avenue SE, Albuquerque, New Mexico 87108, USA
www.richmondproducts.com | Send Inquiry | Phone: +1-(505)-275-2406
Products: Occluders, Maddox Rods, Bagolini Lenses (FDA Code: HPD), Fresnel Prism Bars, Trial Frames, Lanthony Tritan, ...
Richmond Products, Inc. produces screening tests & accessories for ophthalmologists and optometrists. Our product includes aniseikonia, phoropter, chin rest, occluders, prisms, novelty, trial frames, more...
www.richmondproducts.com | Send Inquiry | Phone: +1-(505)-275-2406
Products: Occluders, Maddox Rods, Bagolini Lenses (FDA Code: HPD), Fresnel Prism Bars, Trial Frames, Lanthony Tritan, ...
Richmond Products, Inc. produces screening tests & accessories for ophthalmologists and optometrists. Our product includes aniseikonia, phoropter, chin rest, occluders, prisms, novelty, trial frames, more...
Good-Lite Co. | Address: 1155 Jansen Farm Drive, Elgin, Illinois 60133, USA
www.good-lite.com | Send Inquiry | Phone: +1-(800)-362-3860
FDA Registration: 1418300 Annual Revenues: < USD 1 Million
Products: Instrument Stands, Cabinets, Diagnostic Charts, Eyeshields, IV Catheters & Infusion Sets, General Diagnostic Supplies, ...
Good-Lite Co. manufactures a fine line of vision light boxes, charts and accessories. Our super pinhole macula cabinet can assist with testing potential visual acuity when considering cataract surgery more...
www.good-lite.com | Send Inquiry | Phone: +1-(800)-362-3860
FDA Registration: 1418300 Annual Revenues: < USD 1 Million
Products: Instrument Stands, Cabinets, Diagnostic Charts, Eyeshields, IV Catheters & Infusion Sets, General Diagnostic Supplies, ...
Good-Lite Co. manufactures a fine line of vision light boxes, charts and accessories. Our super pinhole macula cabinet can assist with testing potential visual acuity when considering cataract surgery more...
Vision Assessment Corp. | Address: 2675 Coyle Ave., Elk Grove Village, Illinois 60007, USA
www.visionassessment.com | Send Inquiry | Phone: +1-(847)-239-5889,866-887-9692
FDA Registration: 3006446477
Products: Vision Testers, Visual Acuity Charts (FDA Code: HOX), Projector Slides, Vectographic Slides, Simple Vectographic Slides, Vision Testing Projector Slides, ...
Vision Assessment Corp. specializes in instruments for vision assessment. Our product categories are stereopsis tests, projector slides, vectographs, infant acuity and vision tester. Our adult acuity more...
www.visionassessment.com | Send Inquiry | Phone: +1-(847)-239-5889,866-887-9692
FDA Registration: 3006446477
Products: Vision Testers, Visual Acuity Charts (FDA Code: HOX), Projector Slides, Vectographic Slides, Simple Vectographic Slides, Vision Testing Projector Slides, ...
Vision Assessment Corp. specializes in instruments for vision assessment. Our product categories are stereopsis tests, projector slides, vectographs, infant acuity and vision tester. Our adult acuity 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...
Gulden Ophthalmics | Address: 225 Cadwalader Avenue, Elkins Park, Pennsylvania 19027, USA
www.guldenindustries.com | Send Inquiry | Phone: +1-(215)-884-8105, 800-659-2250
FDA Registration: 2518410 Year Established: 1938 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Eye Shields, Human Eye Model, Eye Gel Mask, Eye Tonometer, Eye Guards, Gel Eye Shields, ...
Gulden Ophthalmic is a manufacturer of ophthalmic instruments and devices. Our product list comprises of cornea eye models, detachment eye models and lighted low vision pens. Our lighted low vision pe more...
www.guldenindustries.com | Send Inquiry | Phone: +1-(215)-884-8105, 800-659-2250
FDA Registration: 2518410 Year Established: 1938 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Eye Shields, Human Eye Model, Eye Gel Mask, Eye Tonometer, Eye Guards, Gel Eye Shields, ...
Gulden Ophthalmic is a manufacturer of ophthalmic instruments and devices. Our product list comprises of cornea eye models, detachment eye models and lighted low vision pens. Our lighted low vision pe more...
Titmus Optical Inc. | Address: 3811 Corporate Drive, Petersburg, Virginia 23805, USA
www.titmus.com | Send Inquiry | Phone: +001-(804)-732-6121
Year Established: 1908 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, ISO 9002, CE Certified
Products: General Diagnostic Supplies, General Medical Supplies, General Disinfectants, General Examination Supplies, General Surgical Instruments, Facial Proctology Kit, ...
Titmus Optical Inc. is an ISO 9001:2000 certified company. We provide products & services to both the optical and industrial community to help improve & protect vision. We focus on vision screening an more...
www.titmus.com | Send Inquiry | Phone: +001-(804)-732-6121
Year Established: 1908 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, ISO 9002, CE Certified
Products: General Diagnostic Supplies, General Medical Supplies, General Disinfectants, General Examination Supplies, General Surgical Instruments, Facial Proctology Kit, ...
Titmus Optical Inc. is an ISO 9001:2000 certified company. We provide products & services to both the optical and industrial community to help improve & protect vision. We focus on vision screening an 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...
Topcon Europe Medical BV | Address: Esse Baan 11, Capelle A/d Yssel 2908, Netherlands
www.topconeurope.com | Send Inquiry | Phone: +31-(10)-458-5077
FDA Registration: 3007913339 Employee Count: ~60
Products: Indirect Ophthalmoscopes, Binocular Indirect Ophthalmoscopes, Laser Indirect Ophthalmoscope, Ophthalmic Instrument Stand (FDA Code: HMG), Monocular Indirect Ophthalmoscope, Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), ...
Topcon Europe Medical BV specializes in opthalmic products. Our product list comprises of retinal cameras, corneal analyzers, slit lamps, specular microscopes and tonometers. Our SP-3000P specular mic more...
www.topconeurope.com | Send Inquiry | Phone: +31-(10)-458-5077
FDA Registration: 3007913339 Employee Count: ~60
Products: Indirect Ophthalmoscopes, Binocular Indirect Ophthalmoscopes, Laser Indirect Ophthalmoscope, Ophthalmic Instrument Stand (FDA Code: HMG), Monocular Indirect Ophthalmoscope, Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), ...
Topcon Europe Medical BV specializes in opthalmic products. Our product list comprises of retinal cameras, corneal analyzers, slit lamps, specular microscopes and tonometers. Our SP-3000P specular mic more...
T.m.i. Company, Ltd. | Address: 2-10, Niiza 1-chome, Niiza city, Saitama 352, Japan
www.tmi-st.com | Send Inquiry | Phone: +81-(048)-481-2501
FDA Registration: 3005619472
Products: Exophthalmometers (FDA Code: HLS), Ultrasonic Surgical Aspirator, Hertel-Type Exophthalmometers, Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets, Surgical Aspirator, Binocular Loupes, ...
T.m.i. Company, Ltd. manufactures and exports ophthalmic instruments. We are an ISO certified company. Our product line comprises of lensmeter, electric pupillometer, deluxe trial lens set, disposable more...
www.tmi-st.com | Send Inquiry | Phone: +81-(048)-481-2501
FDA Registration: 3005619472
Products: Exophthalmometers (FDA Code: HLS), Ultrasonic Surgical Aspirator, Hertel-Type Exophthalmometers, Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets, Surgical Aspirator, Binocular Loupes, ...
T.m.i. Company, Ltd. manufactures and exports ophthalmic instruments. We are an ISO certified company. Our product line comprises of lensmeter, electric pupillometer, deluxe trial lens set, disposable more...
BAR - Advanced Control Systems Ltd. | Address: Beit Yaacobi , Haatzmaut Str., Even Yehuda 40500, Israel
Phone: +972-(9)-899691
Products: Audiometers (FDA Code: EWO), Color Vision Tester (FDA Code: HIT), ...
BAR - Advanced Control Systems Ltd. specializes in offering ENT products. We offer automatic self-operated screening audiometer devices. more...
Phone: +972-(9)-899691
Products: Audiometers (FDA Code: EWO), Color Vision Tester (FDA Code: HIT), ...
BAR - Advanced Control Systems Ltd. specializes in offering ENT products. We offer automatic self-operated screening audiometer devices. more...
Chona Surgical Company | Address: E-209 A, G.T.B ENCLAVE, OPP. G.T.B HOSPITAL, DELHI, Delhi 110 093, India 
www.chonasurgicalco.com | Send Inquiry | Phone: +91-(11)-22595800
Year Established: 1984 Quality: ISO 9001:2000 Certified
Products: Cannulas, AC-Powered Keratoscope (FDA Code: HLQ), Artificial Eye Iris Button (FDA Code: NCK), Color Vision Tester (FDA Code: HIT), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), ...
Chona Surgical Company is a manufacturer & exporter of ophthalmic instruments and equipments. Our ophthalmic surgical instruments include cannulas, disposable blades, needle holders, IOL manipulators, more...
www.chonasurgicalco.com | Send Inquiry | Phone: +91-(11)-22595800
Year Established: 1984 Quality: ISO 9001:2000 Certified
Products: Cannulas, AC-Powered Keratoscope (FDA Code: HLQ), Artificial Eye Iris Button (FDA Code: NCK), Color Vision Tester (FDA Code: HIT), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), ...
Chona Surgical Company is a manufacturer & exporter of ophthalmic instruments and equipments. Our ophthalmic surgical instruments include cannulas, disposable blades, needle holders, IOL manipulators, more...
Bilink International, Inc. | Address: B-104 Panchratan 8th Chopasni Road, Jodhpur, Rajasthan 342003, India
www.bilinkrus.com | Send Inquiry | Phone: +91-(291)-3290876
Quality: ISO 9001:2000 Certified
Products: AC-Powered Ophthalmic Chair (FDA Code: HME), Color Vision Tester (FDA Code: HIT), Manual Ophthalmic Instrument Table (FDA Code: HRK), Cystotome (FDA Code: HNY), Endoscopic Prescription Lens Eyepiece (FDA Code: FDZ), Biological Tissue Ophthalmic Conformer (FDA Code: NQB), ...
Bilink International, Inc. deals with ophthalmic micro-surgical products. Our products include cannulae, ophthalmic consumables, optometry equipment & lenses, steel instruments and titanium instrument more...
www.bilinkrus.com | Send Inquiry | Phone: +91-(291)-3290876
Quality: ISO 9001:2000 Certified
Products: AC-Powered Ophthalmic Chair (FDA Code: HME), Color Vision Tester (FDA Code: HIT), Manual Ophthalmic Instrument Table (FDA Code: HRK), Cystotome (FDA Code: HNY), Endoscopic Prescription Lens Eyepiece (FDA Code: FDZ), Biological Tissue Ophthalmic Conformer (FDA Code: NQB), ...
Bilink International, Inc. deals with ophthalmic micro-surgical products. Our products include cannulae, ophthalmic consumables, optometry equipment & lenses, steel instruments and titanium instrument more...
Appasamy Associates | Address: No.20 SBI Officer's Colony, First Street, Arumbakkam, Chennai -, Tamil Nadu 600106, India
www.appasamy.com | Send Inquiry | Phone: 91-44-2363 0363
FDA Registration: 3000200843
Products: Tonometers, Applanation Tonometers, Bipolar Suction Coagulator, Bipolar Irrigating Coagulator, Automated Perimeter, Hydraulic Operation Table, ...
Appasamy Associates specializes in ophthalmic instruments and equipments. Our ophthalmic products include instruments, equipment, micro surgical hand held instruments & surgical blades, intra ocular l more...
www.appasamy.com | Send Inquiry | Phone: 91-44-2363 0363
FDA Registration: 3000200843
Products: Tonometers, Applanation Tonometers, Bipolar Suction Coagulator, Bipolar Irrigating Coagulator, Automated Perimeter, Hydraulic Operation Table, ...
Appasamy Associates specializes in ophthalmic instruments and equipments. Our ophthalmic products include instruments, equipment, micro surgical hand held instruments & surgical blades, intra ocular l more...
Luneau SA | Address: B.P. 252, Chartres28005 CHARTRES CEDEX F-28005, France
Phone: +33-(237)-252525
Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Endometrial Aspirator (FDA Code: HFF), AC-Powered Ophthalmic Chair (FDA Code: HME), Ocular Esthesiometer (FDA Code: HJC), Color Vision Tester (FDA Code: HIT), Ophthalmic AC-Powered Instrument Stand (FDA Code: HMF), Ophthalmic Prism Bar (FDA Code: HKW), ...
Luneau SA provides AC-powered ophthalmic examination stands. more...
Phone: +33-(237)-252525
Annual Revenues: USD 5-10 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Endometrial Aspirator (FDA Code: HFF), AC-Powered Ophthalmic Chair (FDA Code: HME), Ocular Esthesiometer (FDA Code: HJC), Color Vision Tester (FDA Code: HIT), Ophthalmic AC-Powered Instrument Stand (FDA Code: HMF), Ophthalmic Prism Bar (FDA Code: HKW), ...
Luneau SA provides AC-powered ophthalmic examination stands. more...
Laboratoires Luneau | Address: 1 Avenue De Malaguet, Prunay Le Gillon 28360, France
Phone: +33-(2)-372525
FDA Registration: 8020811
Products: Uterine Curettes (FDA Code: HCY), Straight Uterine Curette w/Regular Tip, Ocular Plethysmograph (FDA Code: JXF), Fiberoptic Non-Metal Vaginal Speculum (FDA Code: HIC), Hygroscopic-Laminaria Cervical Dilator (FDA Code: HDY), Manual Obstetrical Table and Accessories (FDA Code: HHP), ...
Laboratoires Luneau provides electrically operated wheel chair, various models of ophthalmic stand, sterile curettes for vacuum curettage, cervical dilator, ophtalmo-dynamoneter and aesthesiometer. more...
Phone: +33-(2)-372525
FDA Registration: 8020811
Products: Uterine Curettes (FDA Code: HCY), Straight Uterine Curette w/Regular Tip, Ocular Plethysmograph (FDA Code: JXF), Fiberoptic Non-Metal Vaginal Speculum (FDA Code: HIC), Hygroscopic-Laminaria Cervical Dilator (FDA Code: HDY), Manual Obstetrical Table and Accessories (FDA Code: HHP), ...
Laboratoires Luneau provides electrically operated wheel chair, various models of ophthalmic stand, sterile curettes for vacuum curettage, cervical dilator, ophtalmo-dynamoneter and aesthesiometer. more...
Precision Technology Services, Ltd. | Address: 866 Cordova St. East, Vancouver, British Columbia V6A-1M4, Canada 
Phone: +1-(604)-2151467
FDA Registration: 3002633441
Products: Visual Acuity Charts (FDA Code: HOX), Contact Lens (FDA Code: HQD), AC-Powered Automatic Perimeter (FDA Code: HPT), AC-Powered Keratoscope (FDA Code: HLQ), Color Vision Tester (FDA Code: HIT), ...
Precision Technology Services,Ltd.provides color vision tester, corneal topographer and others. Our range of products include multiple brands of medmont automated perimeters, rigid gs1 color vision te more...
Phone: +1-(604)-2151467
FDA Registration: 3002633441
Products: Visual Acuity Charts (FDA Code: HOX), Contact Lens (FDA Code: HQD), AC-Powered Automatic Perimeter (FDA Code: HPT), AC-Powered Keratoscope (FDA Code: HLQ), Color Vision Tester (FDA Code: HIT), ...
Precision Technology Services,Ltd.provides color vision tester, corneal topographer and others. Our range of products include multiple brands of medmont automated perimeters, rigid gs1 color vision te more...
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FDA Code / Regulation: HIT / 886.1170
A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.
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.
