Cleared Traditional

NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL

K895474 · Canon USA, Inc. · Ophthalmic
Oct 1989
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K895474 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL, 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 October 4, 1989, 23 days after receiving the submission on September 11, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K895474 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1989
Decision Date October 04, 1989
Days to Decision 23 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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