FDA 510(k)

Mjolnir Pro.（多電極等离子體）

K 號：K233760 · 2024-02-20

申請人Shenzhen Leaflife Technology Co., Ltd.

決定日期2024-02-20

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

Mjolnir Pro. (Multi–electrode plasma) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-20 under 510(k) number K233760. 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 Mjolnir Pro. (Multi–electrode plasma)?

Mjolnir Pro. (Multi–electrode plasma) is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K233760.

When did Mjolnir Pro. (Multi–electrode plasma) receive FDA 510(k) clearance?

Mjolnir Pro. (Multi–electrode plasma) received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233760.

Who is the listed applicant for Mjolnir Pro. (Multi–electrode plasma)?

The FDA 510(k) record lists Shenzhen Leaflife Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mjolnir Pro. (Multi–electrode plasma)?

The FDA product code for Mjolnir Pro. (Multi–electrode plasma) is QVJ.

其他以 Shenzhen Leaflife Technology Co., Ltd. 為申請人之記錄

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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。

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