FDA 510(k)

MU2net

Número K: K191944 · 2019-10-24

Data da decisão2019-10-24

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

MU2net is the device name listed in this FDA 510(k) record. The listed applicant is Dosisoft. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K191944. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MU2net?

MU2net is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Dosisoft. The 510(k) number is K191944.

When did MU2net receive FDA 510(k) clearance?

MU2net received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191944.

Who is the listed applicant for MU2net?

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

What is the FDA product code for MU2net?

The FDA product code for MU2net is IYE.

Outros registros que listam Dosisoft como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K182966PLANET Onco Dose K180106ThinkQA

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Fonte oficial

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