Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1930 Tonometer and accessories.
§ 886.1930 Tonometer and accessories.
(a) 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.
(b) Classification. Class II.