Cleared Traditional

60 DEGREE FUNDUS CAMERA, CF-60UD

K934663 · Canon USA, Inc. · Ophthalmic
Feb 1994
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K934663 is an FDA 510(k) clearance for the 60 DEGREE FUNDUS CAMERA, CF-60UD, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on February 22, 1994, 147 days after receiving the submission on September 28, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K934663 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1993
Decision Date February 22, 1994
Days to Decision 147 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120