FDA 510(k)

FLIX-EMS

K 號：K181419 · 2019-05-14

決定日期2019-05-14

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

FLIX-EMS is the device name listed in this FDA 510(k) record. The listed applicant is Casgarum Investment, S.L.. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K181419. 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 FLIX-EMS?

FLIX-EMS is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Casgarum Investment, S.L.. The 510(k) number is K181419.

When did FLIX-EMS receive FDA 510(k) clearance?

FLIX-EMS received FDA 510(k) clearance on 2019-05-14, under 510(k) number K181419.

Who is the listed applicant for FLIX-EMS?

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

What is the FDA product code for FLIX-EMS?

The FDA product code for FLIX-EMS is NGX.

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

在 FDA 資料庫中查看 →

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。