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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 Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type PMA
Regulation Number 886.4280
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible