Cleared Traditional

GUNKEL CHROMAGRAPH COLOR VISION TESTER

K860174 · Chromagraphics, Inc. · Ophthalmic
Apr 1986
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K860174 is an FDA 510(k) clearance for the GUNKEL CHROMAGRAPH COLOR VISION TESTER, a Anomaloscope (Class I — General Controls, product code HIW), submitted by Chromagraphics, Inc. (Bethesda, US). The FDA issued a Cleared decision on April 4, 1986, 77 days after receiving the submission on January 17, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1070.

Submission Details

510(k) Number K860174 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1986
Decision Date April 04, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HIW — Anomaloscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1070