Cleared Traditional

WOODLYN APPLANATION TONOMETER

K841762 · Woodlyn, Inc. · Ophthalmic
Aug 1984
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K841762 is an FDA 510(k) clearance for the WOODLYN APPLANATION TONOMETER, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984, 97 days after receiving the submission on April 27, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K841762 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1984
Decision Date August 02, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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