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510(k) Data Aggregation

    K Number
    K990478
    Device Name
    CARD GUARD, MODEL CG-6550
    Manufacturer
    CARD GUARD SCIENTIFIC SURVIVAL, LTD.
    Date Cleared
    1999-08-31

    (196 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARD GUARD, MODEL CG-6550

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.

    Device Description

    Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Card Guard Personal ECG Transmitter Model CG-6550. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter is a regulatory document confirming that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include the technical details of the device's validation.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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