FDA 510(k)

無線頻率發生器系統，Cura RF 電極

K 號：K240758 · 2024-12-11

申請人Zhejiang Curaway Medical Technology Co., Ltd.

決定日期2024-12-11

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

Radiofrequency Generator System, Cura RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K240758. 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 Radiofrequency Generator System, Cura RF Electrode?

Radiofrequency Generator System, Cura RF Electrode is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K240758.

When did Radiofrequency Generator System, Cura RF Electrode receive FDA 510(k) clearance?

Radiofrequency Generator System, Cura RF Electrode received FDA 510(k) clearance on 2024-12-11, under 510(k) number K240758.

Who is the listed applicant for Radiofrequency Generator System, Cura RF Electrode?

FDA 510(k) 記錄將浙江庫瑞威醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Radiofrequency Generator System, Cura RF Electrode?

The FDA product code for Radiofrequency Generator System, Cura RF Electrode is GEI.

其他以 Zhejiang Curaway Medical Technology Co., 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。

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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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