FDA 510(k)

PROBEAT-V and accessories

Número K: K153614 · 2016-04-21

RequerenteHitachi, Ltd., Health Care Company

Data da decisão2016-04-21

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

PROBEAT-V and accessories is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd., Health Care Company. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K153614. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PROBEAT-V and accessories?

PROBEAT-V and accessories is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Hitachi, Ltd., Health Care Company. The 510(k) number is K153614.

When did PROBEAT-V and accessories receive FDA 510(k) clearance?

PROBEAT-V and accessories received FDA 510(k) clearance on 2016-04-21, under 510(k) number K153614.

Who is the listed applicant for PROBEAT-V and accessories?

The FDA 510(k) record lists Hitachi, Ltd., Health Care Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-V and accessories?

The FDA product code for PROBEAT-V and accessories is LHN.

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