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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
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Card Guard Model CG-2206 Personal Electrocardiogram Transmitter. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of letter primarily indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot provide the requested information from the given text.

    To answer your specific questions, I would need a document that describes the design verification and validation studies performed for the device.

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