FDA 510(k)

DReal

Número K: K153519 · 2016-03-16

Data da decisão2016-03-16

Código do produtoHBE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DReal is the device name listed in this FDA 510(k) record. The listed applicant is Carevature Medical, Ltd.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K153519. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DReal?

DReal is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Carevature Medical, Ltd.. The 510(k) number is K153519.

When did DReal receive FDA 510(k) clearance?

DReal received FDA 510(k) clearance on 2016-03-16, under 510(k) number K153519.

Who is the listed applicant for DReal?

The FDA 510(k) record lists Carevature Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DReal?

The FDA product code for DReal is HBE.

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Dispositivos Relacionados (Código: HBE)

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