GUNKEL CHROMAGRAPH COLOR VISION TESTER— 510(k) K860174

Name: FDA 510(k) clearance K860174
Creator: U.S. Food and Drug Administration
Published: 1986-04-04

Substantially Equivalent

Chromagraphics, Inc.

FDA 510(k) clearance K860174 for GUNKEL CHROMAGRAPH COLOR VISION TESTER, Substantially Equivalent on 1986-04-04. Applicant: Chromagraphics, Inc.. Device class: 1.

Clearance details

Applicant: Chromagraphics, Inc.
Product code: Code HIW
Device class: Class 1
Regulation: 21 CFR 886.1070
Advisory panel: Ophthalmic
Date received: 1986-01-17
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIW

view all

K930575 — KAMPPETER ANOMALOSCOPE1994-02-25
K913962 — ANOMALOSCOPE QUADRANT TEST-61991-10-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.