Cleared Traditional

K911439 - NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
(FDA 510(k) Clearance)

K911439 · Canon USA, Inc. · Ophthalmic device

Jun 1991

Decision

76d

Days

Class 2

Risk

K911439 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, CR-45UAF. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).

Submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on June 17, 1991, 76 days after receiving the submission on April 2, 1991.

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

Submission Details

510(k) Number	K911439 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 1991
Decision Date	June 17, 1991
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—