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U.S. Department of Health and Human Services

Product Classification

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Device intraocular, pressure measuring device
Regulation Description Intraocular pressure measuring device.
Definition Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNVB
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Regulation Number 886.4280
Device Class 3
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 Not Third Party Eligible
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