FDA 510(k)

Voluson E6, Voluson E8, Voluson E10

Número K: K162269 · 2016-10-03

Data da decisão2016-10-03

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Voluson E6, Voluson E8, 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 2016-10-03 under 510(k) number K162269. 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 E6, Voluson E8, Voluson E10?

Voluson E6, Voluson E8, Voluson E10 is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is GE Healthcare. The 510(k) number is K162269.

When did Voluson E6, Voluson E8, Voluson E10 receive FDA 510(k) clearance?

Voluson E6, Voluson E8, Voluson E10 received FDA 510(k) clearance on 2016-10-03, under 510(k) number K162269.

Who is the listed applicant for Voluson E6, Voluson E8, 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 E6, Voluson E8, Voluson E10?

The FDA product code for Voluson E6, Voluson E8, Voluson E10 is IYN.

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Fonte oficial

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