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510(k) Data Aggregation

    K Number
    K241613
    Device Name
    Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
    Date Cleared
    2024-10-16

    (133 days)

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

    Shenzhen HBcare Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 ~32 cm.
    Device Description
    The electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. It is effective to reduce the discomfort by wrongly inflating the CUFF and also to reduce the wrong measurement value, thus, it improves the accuracy of the measurement. The device would store 99 groups of measurement values for 2 users and display the average reading of the latest 3 groups of measurement results. The device is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and a LCD liquid crystal display.
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