Cleared Traditional

NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM

K980246 · Canon USA, Inc. · Ophthalmic
May 1998
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K980246 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM, 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 May 6, 1998, 103 days after receiving the submission on January 23, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K980246 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1998
Decision Date May 06, 1998
Days to Decision 103 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