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510(k) Data Aggregation

    K Number
    K140067
    Device Name
    QARDIOARM
    Manufacturer
    QARDIO, INC.
    Date Cleared
    2014-06-18

    (159 days)

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

    QARDIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)
    Device Description
    QardioArm, model A100 measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing. The device includes a plastic enclosure and an integrated wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.
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