FDA 510(k)

電漿筆（Plasma MD）；電漿筆（Plasma +）

K 號：K223440 · 2023-03-02

決定日期2023-03-02

產品代碼QVJ

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

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is the device name listed in this FDA 510(k) record. The listed applicant is Plasma Concepts. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223440. The device is classified under product code QVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Plasma Concepts. The 510(k) number is K223440.

When did Plasma Pen (Plasma MD); Plasma Pen (Plasma +) receive FDA 510(k) clearance?

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223440.

Who is the listed applicant for Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

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

What is the FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

The FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is QVJ.

相關器械（代碼：QVJ）

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。

K233760Mjolnir Pro.（多電極等离子體）Shenzhen Leaflife Technology Co., Ltd.K220493Plaxpot多等离子體設備Gcs Co. Limited K213247JETT 電子血漿機型 IICompex, Spol, S.R.O.

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QVJ）

官方來源