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U.S. Department of Health and Human Services

Product Classification

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Device camera, ophthalmic, ac-powered
Regulation Description Ophthalmic camera.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHKI
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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