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510(k) Data Aggregation

    K Number
    K081603
    Device Name
    DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
    Manufacturer
    HEARTFORCE MEDICAL, INC.
    Date Cleared
    2009-07-24

    (413 days)

    Product Code
    DXR, DSB, INT
    Regulation Number
    870.2320
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEARTFORCE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
    Device Description
    The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.
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