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U.S. Department of Health and Human Services

Product Classification

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Device preamplifier, battery-powered, ophthalmic
Regulation Description Ophthalmic preamplifier.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHLW
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1640
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
Third Party Review
Accredited Persons
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