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FDA 510(k)

EpiFinder

K-Number: K221974 · 2023-04-16

ApplicantOmeq Medical , Ltd.
Decision Date2023-04-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EpiFinder is a medical device manufactured by Omeq Medical , Ltd.. It received FDA 510(k) clearance on 2023-04-16 under approval number K221974. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EpiFinder?

EpiFinder is a medical device that received FDA 510(k) clearance on 2023-04-16. It is manufactured by Omeq Medical , Ltd.. The 510(k) number is K221974.

When was EpiFinder approved by the FDA?

EpiFinder received FDA 510(k) clearance on 2023-04-16, under approval number K221974.

What company makes EpiFinder?

EpiFinder is manufactured by Omeq Medical , Ltd..

What is the FDA product code for EpiFinder?

The FDA product code for EpiFinder is FMF.

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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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