FDA 510(k)

麥可萊數位血壓監測器

K 號：K183469 · 2019-03-12

決定日期2019-03-12

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Microlife Digital Blood Pressure Monitor 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 2019-03-12 under 510(k) number K183469. 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 Digital Blood Pressure Monitor?

Microlife Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K183469.

When did Microlife Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Microlife Digital Blood Pressure Monitor received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183469.

Who is the listed applicant for Microlife Digital Blood Pressure Monitor?

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 Digital Blood Pressure Monitor?

The FDA product code for Microlife Digital Blood Pressure Monitor is DXN.

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

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K230075麥可萊上臂自動數字血壓監測器，型號 BP3KVl-5K K222979麥可萊上臂自動數字血壓監測器，型號 BP3KV1-5W K222153麥可萊上臂自動數字脈搏血壓計，型號 WatchBP Office 腕動脈（TWIN200 VSR）K211776麥可萊非接觸式紅外線額頭溫度計，型號FR1MF1-B（NC150 BT）K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B K202729麥可萊上臂自動數字血壓監測器

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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.

官方來源

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