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Code · CFR · Title 21 — Food and Drugs · Part 886 — Ophthalmic Devices · § 886.1930

§ 886.1930. Tonometer and accessories.

79 words·~1 min read·/us/cfr/t21/s§ 886.1930·

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(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.
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