FDA 510(k)

ビーマーAVEO電気外科発生器、ビーマーAVEOアルゴンモジュール、ビーマーAVEOカート、ビーマーAVEOワイヤードフットペダル、ビーマーAVEOアルゴン圧力調節器

K番号: K214058 · 2022-08-26

決定日2022-08-26

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

申請者としてConmed Corporationを記載するその他の記録

K261363Y-Knotless™ Flex Anchors K253763Y-Knotless™ Flex Anchors K252946バイオブレース® 関節外靭帯強化キット K251530CONMED アルゴノットレス® アンカー K250395バイオブレース®RCデリバリーシステム K244025Argo Knotless GENESYS Anchor

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