Cleared Traditional

CANON AUTO REF-KERATOMETER RK-2

K895475 · Canon USA, Inc. · Ophthalmic
Oct 1989
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K895475 is an FDA 510(k) clearance for the CANON AUTO REF-KERATOMETER RK-2, a Keratoscope, Ac-powered (Class I — General Controls, product code HLQ), submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on October 31, 1989, 50 days after receiving the submission on September 11, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1350.

Submission Details

510(k) Number K895475 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1989
Decision Date October 31, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLQ — Keratoscope, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1350

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