Cleared Traditional

NIDEK HANDY

K973218 · Nidek, Inc. · Ophthalmic
Nov 1997
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K973218 is an FDA 510(k) clearance for the NIDEK HANDY, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on November 4, 1997, 69 days after receiving the submission on August 27, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K973218 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1997
Decision Date November 04, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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