美敦力Commander Flex
K 號：K191745 · 2020-05-15
廣告
器材摘要
Medtronic Commander Flex is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Care Management Services. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K191745. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Medtronic Commander Flex?
Medtronic Commander Flex is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Medtronic Care Management Services. The 510(k) number is K191745.
When did Medtronic Commander Flex receive FDA 510(k) clearance?
Medtronic Commander Flex received FDA 510(k) clearance on 2020-05-15, under 510(k) number K191745.
Who is the listed applicant for Medtronic Commander Flex?
The FDA 510(k) record lists Medtronic Care Management Services as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medtronic Commander Flex?
The FDA product code for Medtronic Commander Flex is DXN.
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。
相關器械（代碼：DXN）
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。
K261929上臂血壓監測器（BP7155D）OMRON Healthcare, Inc.K254000快樂健康血壓監測器Happy Health, Inc.K262658自動數位血壓監測器（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动數字血壓監測儀（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, 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。
廣告