MMAC II TONOMETER

K884012 · Professional Technologies Corp. · HKX · Jan 6, 1989 · Ophthalmic

Device Facts

Record IDK884012
Device NameMMAC II TONOMETER
ApplicantProfessional Technologies Corp.
Product CodeHKX · Ophthalmic
Decision DateJan 6, 1989
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 886.1930
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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