FDA 510(k)

貝美治療系統Evo

K 號：K231368 · 2023-06-09

決定日期2023-06-09

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Bemer Therapy System Evo is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K231368. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bemer Therapy System Evo?

Bemer Therapy System Evo is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Bemer Int AG. The 510(k) number is K231368.

When did Bemer Therapy System Evo receive FDA 510(k) clearance?

Bemer Therapy System Evo received FDA 510(k) clearance on 2023-06-09, under 510(k) number K231368.

Who is the listed applicant for Bemer Therapy System Evo?

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

What is the FDA product code for Bemer Therapy System Evo?

The FDA product code for Bemer Therapy System Evo is NGX.

其他以 Bemer Int AG 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。

K223919B.Light Clear Evo 及 B.Light Restore Evo K210174BEMER 治療系統, BEMER Classic Set, BEMER Pro-Set K151834BEMER Classic Set, BEMER Pro-Set

相關器械（代碼：NGX）

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。

K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology Limited K253926迪阿科爾ShenB Co., Ltd.K253636Zionic Pro Max (電動肌肉刺激器)Termosalud S.L.K253408涼頻Zimmer Medizinsysteme GmbH K252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.

官方來源

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