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FDA 510(k)

GUNKEL CHROMAGRAPH COLOR VISION TESTER

K-Number: K860174 · 1986-04-04

ApplicantChromagraphics, Inc.
Decision Date1986-04-04
Product CodeHIW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GUNKEL CHROMAGRAPH COLOR VISION TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Chromagraphics, Inc.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K860174. The device is classified under product code HIW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUNKEL CHROMAGRAPH COLOR VISION TESTER?

GUNKEL CHROMAGRAPH COLOR VISION TESTER is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Chromagraphics, Inc.. The 510(k) number is K860174.

When did GUNKEL CHROMAGRAPH COLOR VISION TESTER receive FDA 510(k) clearance?

GUNKEL CHROMAGRAPH COLOR VISION TESTER received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860174.

Who is the listed applicant for GUNKEL CHROMAGRAPH COLOR VISION TESTER?

The FDA 510(k) record lists Chromagraphics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUNKEL CHROMAGRAPH COLOR VISION TESTER?

The FDA product code for GUNKEL CHROMAGRAPH COLOR VISION TESTER is HIW.

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Related Devices (Code: HIW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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