FDA 510(k)

Encevis

Número K: K211452 · 2021-12-02

RequerenteAustrian Institute of Technology GmbH

Data da decisão2021-12-02

Código do produtoOMB

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Encevis is the device name listed in this FDA 510(k) record. The listed applicant is Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K211452. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Encevis?

Encevis is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Austrian Institute of Technology GmbH. The 510(k) number is K211452.

When did Encevis receive FDA 510(k) clearance?

Encevis received FDA 510(k) clearance on 2021-12-02, under 510(k) number K211452.

Who is the listed applicant for Encevis?

The FDA 510(k) record lists Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Encevis?

The FDA product code for Encevis is OMB.

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