Cleared Traditional

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

K014274 · Nidek, Inc. · Ophthalmic
Apr 2002
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K014274 is an FDA 510(k) clearance for the NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 17, 2002, 111 days after receiving the submission on December 27, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K014274 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2001
Decision Date April 17, 2002
Days to Decision 111 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