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FDA 510(k)

ACE 電外科切除及氣化電極系列

K 號：K153055 · 2016-07-11

申請人Ace Medical Devices Pvt. , Ltd.
決定日期2016-07-11
產品代碼GEI
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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