FDA 510(k)

Epitomee

Número K: K240544 · 2024-09-13

Data da decisão2024-09-13

Código do produtoQFQ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Epitomee is the device name listed in this FDA 510(k) record. The listed applicant is Epitomee Medical , Ltd.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240544. The device is classified under product code QFQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Epitomee?

Epitomee is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Epitomee Medical , Ltd.. The 510(k) number is K240544.

When did Epitomee receive FDA 510(k) clearance?

Epitomee received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240544.

Who is the listed applicant for Epitomee?

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

What is the FDA product code for Epitomee?

The FDA product code for Epitomee is QFQ.

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Fonte oficial

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