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510(k) Data Aggregation

    K Number
    K062033
    Device Name
    BP 101 DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    KING YIELD HONGKONG LIMITED
    Date Cleared
    2007-03-23

    (248 days)

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

    KING YIELD HONGKONG LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BP101 Digital Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm using the oscillometric method. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can not be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
    Device Description
    BP101 Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the upper arm. BP101 Digital Blood Pressure Monitor uses an inflated cuff which is The systolic and diastolic blood pressures are determined by Oscillometric method. The deflation rate is controlled by an automatic air-release valve at a constant rate 2~7mmHg/second. The user can deflate the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
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