FDA 510(k)

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer

Numéro K : K214058 · 2022-08-26

Date de décision2022-08-26

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K214058. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer?

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Conmed Corporation. The 510(k) number is K214058.

When did Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer receive FDA 510(k) clearance?

Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer received FDA 510(k) clearance on 2022-08-26, under 510(k) number K214058.

Who is the listed applicant for Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer?

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

What is the FDA product code for Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer?

The FDA product code for Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer is GEI.

Essais cliniques associés

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Source officielle

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