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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 Ophthalmic Devices (DHT1A)
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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