FDA 510(k)

麥可萊上臂自動數字血壓監測器，型號 BP3MW1-4Y

K 號：K172498 · 2017-10-13

決定日期2017-10-13

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K172498. 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 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K172498.

When did Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y receive FDA 510(k) clearance?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y received FDA 510(k) clearance on 2017-10-13, under 510(k) number K172498.

Who is the listed applicant for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y?

The FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y is DXN.

其他以 Microlife Intellectual Property GmbH 為申請人之記錄

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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.

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