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510(k) Data Aggregation

    K Number
    K963725
    Device Name
    MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
    Manufacturer
    CARD GUARD LTD.
    Date Cleared
    1997-09-10

    (415 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARD GUARD LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device intended for use by patients who experience transient symptoms that , may suggest cardiac arrythmia. The device is not intended for the simultaneous recording and transmitting of the . patient's ECG signals.
    Device Description
    Card Guard Model CG-2206 Personal Electrocardiogram Transmitter.
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