Cleared Traditional

NON-MYDRIATIC RETINAL CAMERA

K941234 · Canon USA, Inc. · Ophthalmic
Jun 1995
Decision
449d
Days
Class 2
Risk

About This 510(k) Submission

K941234 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, 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 June 7, 1995, 449 days after receiving the submission on March 15, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K941234 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1994
Decision Date June 07, 1995
Days to Decision 449 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