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FDA 510(k)

Capenergy C 裝置 RF 系統 - C25、C50、C100、C200、C300、C400、C500

K 號：K222260 · 2023-03-28

申請人Capenergy Medical S.L.
決定日期2023-03-28
產品代碼PBX
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

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is the device name listed in this FDA 510(k) record. The listed applicant is Capenergy Medical S.L.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K222260. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Capenergy Medical S.L.. The 510(k) number is K222260.

When did Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 receive FDA 510(k) clearance?

Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K222260.

Who is the listed applicant for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

The FDA 510(k) record lists Capenergy Medical S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500?

The FDA product code for Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 is PBX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Capenergy Medical S.L. 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。

K253480Capenergy C 裝置 RF C200 及 C400 DrakarianK191202CAPENERGY - C100、C200、C300、C400、C50

相關器械（代碼：PBX）

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。

K243223多療法美容治療設備（BHS 202 UNYQUE）Bh Group Us, LLCK253480Capenergy C 裝置 RF C200 及 C400 DrakarianCapenergy Medical S.L.K260647規範化醫療設備名稱：SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV 裝置Pollogen, Ltd.

官方來源

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