FDA 510(k)

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

K 號：K211288 · 2021-11-04

決定日期2021-11-04

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B 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 2021-11-04 under 510(k) number K211288. 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 Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211288.

When did Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B receive FDA 510(k) clearance?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B received FDA 510(k) clearance on 2021-11-04, under 510(k) number K211288.

Who is the listed applicant for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

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 Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is DXN.

其他以 Microlife Intellectual Property GmbH 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。

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）K202729麥可萊上臂自動數字血壓監測器 K200738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。

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官方來源

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