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510(k) Data Aggregation

    K Number
    K033216
    Device Name
    BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
    Date Cleared
    2004-05-04

    (214 days)

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

    THE BUZZ GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.
    Device Description
    The Model BZ-576 Digital Blood Pressure Monitor uses the oscillometric method with Fuzzy arithmetic for measuring blood pressure, and the high accuracy and repeatability are achieved. The device is ideal for people who frequently monitor their own blood pressure, for its easy way to use at home, at work and during travel. The main components include a cuff, an integrated silicon pressure sensor, an electronic pump, an electronic valve, two buttons, a microcontroller and LCD display. The integrated silicon pressure sensor is used for detecting pressure within the cuff and the pulse wave component during the course of cuff pressure deflation, and guarantees the long period stability. The air pressure of inflation, deflation and rapid release are fully automatic by using an electronic pump and an electronic valve, and a constant deflation speed is controlled in the process of measurement for increasing the accuracy and reducing the measurement time. The blood pressure and pulse values are calculated, and are displayed with "mmHg" or "kPa" on LCD alternatively.
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