FDA 510(k)

ACE 電気外科切除および蒸気化電極シリーズ

K番号: K153055 · 2016-07-11

決定日2016-07-11

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

決定大幅同等

医療機器の概要

ACE Electrosurgical Resection and Vaporization Electrodes Series is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Devices Pvt. , Ltd.. It received FDA 510(k) clearance on 2016-07-11 under 510(k) number K153055. 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 ACE Electrosurgical Resection and Vaporization Electrodes Series?

ACE Electrosurgical Resection and Vaporization Electrodes Series is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Ace Medical Devices Pvt. , Ltd.. The 510(k) number is K153055.

When did ACE Electrosurgical Resection and Vaporization Electrodes Series receive FDA 510(k) clearance?

ACE Electrosurgical Resection and Vaporization Electrodes Series received FDA 510(k) clearance on 2016-07-11, under 510(k) number K153055.

Who is the listed applicant for ACE Electrosurgical Resection and Vaporization Electrodes Series?

The FDA 510(k) record lists Ace Medical Devices Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE Electrosurgical Resection and Vaporization Electrodes Series?

The FDA product code for ACE Electrosurgical Resection and Vaporization Electrodes Series is GEI.

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ACE 電気外科切除および蒸気化電極シリーズ

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEI）

公式ソース