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510(k) Data Aggregation

    K Number
    K173028
    Device Name
    BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
    Manufacturer
    HealthSTATS International Pte Ltd
    Date Cleared
    2018-06-21

    (266 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HealthSTATS International Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BPro® BT Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT software, a PC-based computer program. Before each measurement session, the wrist device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure and pulse rate over a period of 24 hours. BProSOft BT PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 24-hour period. The BPro BT system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. The BPro BT system is intended only for measurement, recording, and display. It makes no diagnosis.
    Device Description
    HealthSTATS BPro® BT Ambulatory Blood Pressure Monitoring System with BProSOft PC software is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements: - BPro BT wrist-mounted tonometric monitor. - BProSoft BT report management software, a PC-based computer program. - BPCalibrator MC3100+ oscillometric blood pressure monitor [listed device, K131788] for calibration of BPro BT monitor. Once the BPro BT is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. Blood pressure measurements obtained over the 24 hour period are transferred wirelessly by the BProSoft BT PC software for storage, display, and reports.
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