FDA 510(k)

Nutrisafe 2- ENFit Adaptor

Número K: K151237 · 2016-02-09

RequerenteVygon

Data da decisão2016-02-09

Código do produtoPIO

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nutrisafe 2- ENFit Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Vygon. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151237. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nutrisafe 2- ENFit Adaptor?

Nutrisafe 2- ENFit Adaptor is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Vygon. The 510(k) number is K151237.

When did Nutrisafe 2- ENFit Adaptor receive FDA 510(k) clearance?

Nutrisafe 2- ENFit Adaptor received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151237.

Who is the listed applicant for Nutrisafe 2- ENFit Adaptor?

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

What is the FDA product code for Nutrisafe 2- ENFit Adaptor?

The FDA product code for Nutrisafe 2- ENFit Adaptor is PIO.

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Fonte oficial

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