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FDA 510(k)

EXPRESSEYE

K-Number: K992473 · 1999-08-12

ApplicantOptomotor Laboratories
Decision Date1999-08-12
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXPRESSEYE is the device name listed in this FDA 510(k) record. The listed applicant is Optomotor Laboratories. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K992473. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPRESSEYE?

EXPRESSEYE is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Optomotor Laboratories. The 510(k) number is K992473.

When did EXPRESSEYE receive FDA 510(k) clearance?

EXPRESSEYE received FDA 510(k) clearance on 1999-08-12, under 510(k) number K992473.

Who is the listed applicant for EXPRESSEYE?

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

What is the FDA product code for EXPRESSEYE?

The FDA product code for EXPRESSEYE is GWN.

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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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