FDA 510(k)

Revi™ 系統

K 號：K240037 · 2024-05-02

決定日期2024-05-02

產品代碼QXM

諮詢委員會GU

決定相當於

器材摘要

Revi™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bluewind Medical , Ltd.. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K240037. The device is classified under product code QXM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Revi™ System?

Revi™ System is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is Bluewind Medical , Ltd.. The 510(k) number is K240037.

When did Revi™ System receive FDA 510(k) clearance?

Revi™ System received FDA 510(k) clearance on 2024-05-02, under 510(k) number K240037.

Who is the listed applicant for Revi™ System?

FDA 510(k) 記錄將 Bluewind Medical, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Revi™ System?

The FDA product code for Revi™ System is QXM.

其他以 Bluewind Medical , Ltd. 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。

K253651Revi 系統 K252391Revi 系統

相關器械（代碼：QXM）

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。

K253651Revi 系統Bluewind Medical , Ltd.K252391Revi 系統Bluewind Medical , Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。