21 CFR 886.1930 — Tonometer, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1930

Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HKXTonometer, Ac-Powered258
HKYTonometer, Manual2563rd Party
HLACalibrator, Tonometer203rd Party
HPKTonograph203rd Party
NJJTonometer, Analyzer, Ocular Blood Flow213rd Party
Innolitics

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