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FDA 510(k)

APPARATUS & METHODS SELF-EXAM OF EYE

K-Number: K843702 · 1985-01-03

ApplicantWheel Checkers
Decision Date1985-01-03
Product CodeHOQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

APPARATUS & METHODS SELF-EXAM OF EYE is the device name listed in this FDA 510(k) record. The listed applicant is Wheel Checkers. It received FDA 510(k) clearance on 1985-01-03 under 510(k) number K843702. The device is classified under product code HOQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPARATUS & METHODS SELF-EXAM OF EYE?

APPARATUS & METHODS SELF-EXAM OF EYE is a medical device that received FDA 510(k) clearance on 1985-01-03. The listed applicant is Wheel Checkers. The 510(k) number is K843702.

When did APPARATUS & METHODS SELF-EXAM OF EYE receive FDA 510(k) clearance?

APPARATUS & METHODS SELF-EXAM OF EYE received FDA 510(k) clearance on 1985-01-03, under 510(k) number K843702.

Who is the listed applicant for APPARATUS & METHODS SELF-EXAM OF EYE?

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

What is the FDA product code for APPARATUS & METHODS SELF-EXAM OF EYE?

The FDA product code for APPARATUS & METHODS SELF-EXAM OF EYE is HOQ.

Related Clinical Trials

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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Other records listing Wheel Checkers as applicant

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.

K863429MODIFIED DEVICE FOR SELF EXAMINATION OF EYES

Related Devices (Code: HOQ)

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.

K180895AlleyeOculocare Medical AGK121738MYVISIONTRACK(TM)Vital Art and Science IncorporatedK014044MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)Notal Vision, Inc.K874252KREDA DISCRichmond Products, Inc.K863429MODIFIED DEVICE FOR SELF EXAMINATION OF EYESWheel CheckersK843227MACULAR FUNCTION ANALYZERDanek Medical, Inc.

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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