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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 the device name listed in this FDA 510(k) record. The listed applicant is Omeq Medical , Ltd.. It received FDA 510(k) clearance on 2023-04-16 under 510(k) 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. The listed applicant is Omeq Medical , Ltd.. The 510(k) number is K221974.

When did EpiFinder receive FDA 510(k) clearance?

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

Who is the listed applicant for EpiFinder?

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

What is the FDA product code for EpiFinder?

The FDA product code for EpiFinder is FMF.

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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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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