FDA 510(k)

Voyant Fine Fusion

Número K: K153017 · 2016-07-06

Data da decisão2016-07-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Voyant Fine Fusion is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K153017. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Voyant Fine Fusion?

Voyant Fine Fusion is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Applied Medical Resources. The 510(k) number is K153017.

When did Voyant Fine Fusion receive FDA 510(k) clearance?

Voyant Fine Fusion received FDA 510(k) clearance on 2016-07-06, under 510(k) number K153017.

Who is the listed applicant for Voyant Fine Fusion?

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

What is the FDA product code for Voyant Fine Fusion?

The FDA product code for Voyant Fine Fusion is GEI.

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