FDA 510(k)

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

Número K: K153421 · 2016-01-21

RequerenteHitachi Aloka Medical America, Inc.

Data da decisão2016-01-21

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153421. 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 HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Hitachi Aloka Medical America, Inc.. The 510(k) number is K153421.

When did HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS receive FDA 510(k) clearance?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153421.

Who is the listed applicant for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

The FDA 510(k) record lists Hitachi Aloka Medical America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

The FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is IYN.

Ensaios clínicos relacionados

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Outros registros que listam Hitachi Aloka Medical America, Inc. como candidato(a)

K152126UST-5550-R; UST-5536-R; L43K

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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