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FDA 510(k)

麥可萊上臂自動數字血壓監測器,型號 BP Progress (BP3T01-1B)

K 號:K251120 · 2025-08-06

決定日期2025-08-06
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 BP Progress (BP3T01-1B) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Corporation. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K251120. 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 BP Progress (BP3T01-1B)?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is a medical device that received FDA 510(k) clearance on 2025-08-06. The listed applicant is Microlife Corporation. The 510(k) number is K251120.

When did Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) receive FDA 510(k) clearance?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) received FDA 510(k) clearance on 2025-08-06, under 510(k) number K251120.

Who is the listed applicant for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)?

FDA 510(k) 記錄中將 Microlife Corporation 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)?

The FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) 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。

其他以 Microlife Corporation 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。

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。

官方來源

在 FDA 資料庫中查看 →

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