Cleared Traditional

K946058 - 60 FUNDUS CAMERA CF-60UV
(FDA 510(k) Clearance)

K946058 · Canon USA, Inc. · Ophthalmic device

Feb 1995

Decision

87d

Days

Class 2

Risk

K946058 is an FDA 510(k) clearance for the 60 FUNDUS CAMERA CF-60UV. This device is classified as 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 3, 1995, 87 days after receiving the submission on November 8, 1994.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K946058 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 08, 1994
Decision Date	February 03, 1995
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement