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FDA 510(k)

BPro BT 運動血壓監測系統搭配 BProSoft BT PC 軟體

K 號：K173028 · 2018-06-21

申請人Healthstats International Pte. , Ltd.
決定日期2018-06-21
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is the device name listed in this FDA 510(k) record. The listed applicant is Healthstats International Pte. , Ltd.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K173028. 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 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Healthstats International Pte. , Ltd.. The 510(k) number is K173028.

When did BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software receive FDA 510(k) clearance?

BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software received FDA 510(k) clearance on 2018-06-21, under 510(k) number K173028.

Who is the listed applicant for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

The FDA 510(k) record lists Healthstats International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software?

The FDA product code for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software 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。

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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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