FDA 510(k)

Voyant Open Fusion Device

Número K: K162676 · 2016-12-01

Data da decisão2016-12-01

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Voyant Open Fusion Device 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 2016-12-01 under 510(k) number K162676. 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 Open Fusion Device?

Voyant Open Fusion Device is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Applied Medical Resources. The 510(k) number is K162676.

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

Voyant Open Fusion Device received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162676.

Who is the listed applicant for Voyant Open Fusion Device?

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 Open Fusion Device?

The FDA product code for Voyant Open Fusion Device is GEI.

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Outros registros que listam Applied Medical Resources como candidato(a)

K200021Applied Medical Anoscope K153017Voyant Fine Fusion K153288Voyant Open Fusion Device K151480Epix Electrosurgical Probe with Smoke Evacuation

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