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510(k) Data Aggregation

    K Number
    K040159
    Device Name
    APM BLOOD PRESSURE MONITOR, MODEL BP108A
    Manufacturer
    ASIA PACIFIC MICROSYSTEMS, INC.
    Date Cleared
    2004-03-22

    (59 days)

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

    ASIA PACIFIC MICROSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device as a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"-7.75".
    Device Description
    APM BP108A uses the Oscillomeric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse Through simple calculation, clinically proven, the reading can reflect the signal. accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
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