FDA 510(k)

Werewolf RF20000 Controller, FLOW 50 Wand

Número K: K162074 · 2016-08-22

Data da decisão2016-08-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Werewolf RF20000 Controller, FLOW 50 Wand is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K162074. 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 Werewolf RF20000 Controller, FLOW 50 Wand?

Werewolf RF20000 Controller, FLOW 50 Wand is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is ArthroCare Corporation. The 510(k) number is K162074.

When did Werewolf RF20000 Controller, FLOW 50 Wand receive FDA 510(k) clearance?

Werewolf RF20000 Controller, FLOW 50 Wand received FDA 510(k) clearance on 2016-08-22, under 510(k) number K162074.

Who is the listed applicant for Werewolf RF20000 Controller, FLOW 50 Wand?

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

What is the FDA product code for Werewolf RF20000 Controller, FLOW 50 Wand?

The FDA product code for Werewolf RF20000 Controller, FLOW 50 Wand is GEI.

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Fonte oficial

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