FDA 510(k)

Voluson E10

Número K: K201768 · 2020-10-22

Data da decisão2020-10-22

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Voluson E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K201768. 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 Voluson E10?

Voluson E10 is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is GE Healthcare. The 510(k) number is K201768.

When did Voluson E10 receive FDA 510(k) clearance?

Voluson E10 received FDA 510(k) clearance on 2020-10-22, under 510(k) number K201768.

Who is the listed applicant for Voluson E10?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voluson E10?

The FDA product code for Voluson E10 is IYN.

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Fonte oficial

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