FDA 510(k)

Surn5 電外科氩激光發射器及配件

K 號：K203522 · 2021-02-22

決定日期2021-02-22

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

Surn5 Electrosurgical Argon Beam Generator and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Surnic Corporation. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K203522. 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 Surn5 Electrosurgical Argon Beam Generator and Accessories?

Surn5 Electrosurgical Argon Beam Generator and Accessories is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Surnic Corporation. The 510(k) number is K203522.

When did Surn5 Electrosurgical Argon Beam Generator and Accessories receive FDA 510(k) clearance?

Surn5 Electrosurgical Argon Beam Generator and Accessories received FDA 510(k) clearance on 2021-02-22, under 510(k) number K203522.

Who is the listed applicant for Surn5 Electrosurgical Argon Beam Generator and Accessories?

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

What is the FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories?

The FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories is GEI.

其他以 Surnic Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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