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FDA 510(k)

RETINA TESTER

K-Number: K914393 · 1992-03-02

ApplicantRetina Tester
Decision Date1992-03-02
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINA TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Retina Tester. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K914393. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETINA TESTER?

RETINA TESTER is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Retina Tester. The 510(k) number is K914393.

When did RETINA TESTER receive FDA 510(k) clearance?

RETINA TESTER received FDA 510(k) clearance on 1992-03-02, under 510(k) number K914393.

Who is the listed applicant for RETINA TESTER?

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

What is the FDA product code for RETINA TESTER?

The FDA product code for RETINA TESTER is HLX.

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Related Devices (Code: HLX)

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

View on FDA Database →

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

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