FDA 510(k)

ARIETTA 50

Número K: K190248 · 2019-04-02

Data da decisão2019-04-02

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARIETTA 50 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-04-02 under 510(k) number K190248. 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 ARIETTA 50?

ARIETTA 50 is a medical device that received FDA 510(k) clearance on 2019-04-02. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K190248.

When did ARIETTA 50 receive FDA 510(k) clearance?

ARIETTA 50 received FDA 510(k) clearance on 2019-04-02, under 510(k) number K190248.

Who is the listed applicant for ARIETTA 50?

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

What is the FDA product code for ARIETTA 50?

The FDA product code for ARIETTA 50 is IYN.

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Fonte oficial

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