FDA 510(k)

X-CUBE i8, X-CUBE i9

Número K: K213523 · 2022-01-28

RequerenteAlpinion Medical Systems Co., Ltd.

Data da decisão2022-01-28

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

X-CUBE i8, X-CUBE i9 is the device name listed in this FDA 510(k) record. The listed applicant is Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213523. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the X-CUBE i8, X-CUBE i9?

X-CUBE i8, X-CUBE i9 is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K213523.

When did X-CUBE i8, X-CUBE i9 receive FDA 510(k) clearance?

X-CUBE i8, X-CUBE i9 received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213523.

Who is the listed applicant for X-CUBE i8, X-CUBE i9?

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

What is the FDA product code for X-CUBE i8, X-CUBE i9?

The FDA product code for X-CUBE i8, X-CUBE i9 is IYN.

Outros registros que listam Alpinion Medical Systems Co., Ltd. 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.

K223564X-CUBE 50, X-CUBE 60 K221093X-CUBE 70, X-CUBE 90 K220857X-CUBE 50, X-CUBE 60 K211299X-CUBE 70 K211300X-CUBE 90 K200449X-Cube 90

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Dispositivos Relacionados (Código: IYN)

Fonte oficial

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