FDA 510(k)

EpiFinder

Número K: K221974 · 2023-04-16

Data da decisão2023-04-16

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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