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510(k) Data Aggregation

    K Number
    K022926
    Device Name
    GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
    Manufacturer
    GENTEEL TECHNOLOGY CO., LTD.
    Date Cleared
    2003-06-06

    (306 days)

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

    GENTEEL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.
    Device Description
    GENTEEL BP-100 Wrist Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
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