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510(k) Data Aggregation

    K Number
    K122810
    Device Name
    COMPACT DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    Date Cleared
    2013-02-08

    (148 days)

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

    THERMOR LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Compact Blood Pressure Monitor is intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The device is reusable and intended for home use on adults.
    Device Description
    The Compact Blood Pressure Monitor, model BD204 is designed to measure systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Rather than using the ausculatory method, which employs either an aneroid gauge or mercury manometer with a stethoscope to determine systolic and diastolic pressure, the device uses the oscillometric method, wherein an electronic semiconductor - sensor in the cuff determines the measurements. The sensor converts minute alterations in cuff pressure to electrical signals, by analyzing the amplitude of those signals systolic and diastolic pressure and pulse rates are calculated. The device analyses the signals and displays the results immediately.
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