Cleared Traditional

CANON TX-10 TONOMETER

K963079 · Canon USA, Inc. · Ophthalmic
Mar 1997
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K963079 is an FDA 510(k) clearance for the CANON TX-10 TONOMETER, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 3, 1997, 208 days after receiving the submission on August 7, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K963079 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1996
Decision Date March 03, 1997
Days to Decision 208 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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