FDA 510(k)

minisono

Número K: K182845 · 2018-12-27

RequerenteAlpinion Medical Systems Co., Ltd.

Data da decisão2018-12-27

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

minisono 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 2018-12-27 under 510(k) number K182845. 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 minisono?

minisono is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K182845.

When did minisono receive FDA 510(k) clearance?

minisono received FDA 510(k) clearance on 2018-12-27, under 510(k) number K182845.

Who is the listed applicant for minisono?

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 minisono?

The FDA product code for minisono is IYN.

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Outros registros que listam Alpinion Medical Systems Co., Ltd. como candidato(a)

K223564X-CUBE 50, X-CUBE 60 K221093X-CUBE 70, X-CUBE 90 K220857X-CUBE 50, X-CUBE 60 K213523X-CUBE i8, X-CUBE i9 K211300X-CUBE 90 K211299X-CUBE 70

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Dispositivos Relacionados (Código: IYN)

Fonte oficial

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