FDA 510(k)

Aloka Arietta 850

Número K: K183456 · 2019-01-28

Data da decisão2019-01-28

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aloka Arietta 850 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 2019-01-28 under 510(k) number K183456. 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 Aloka Arietta 850?

Aloka Arietta 850 is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K183456.

When did Aloka Arietta 850 receive FDA 510(k) clearance?

Aloka Arietta 850 received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183456.

Who is the listed applicant for Aloka Arietta 850?

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 Aloka Arietta 850?

The FDA product code for Aloka Arietta 850 is IYN.

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Fonte oficial

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