Cleared Traditional

60 FUNDUS CAMERA CF-60UV

K901839 · Canon USA, Inc. · Ophthalmic
Jul 1990
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K901839 is an FDA 510(k) clearance for the 60 FUNDUS CAMERA CF-60UV, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on July 5, 1990, 72 days after receiving the submission on April 24, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number K901839 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1990
Decision Date July 05, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJI — Lens, Fundus, Hruby, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1395

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