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510(k) Data Aggregation

    K Number
    K983026
    Device Name
    PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
    Manufacturer
    CARD GUARD SCIENTIFIC SURVIVAL, LTD.
    Date Cleared
    1998-12-02

    (93 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to assist doctors in checking implanted pacing systems of ambulatory patients. The device transmits the patient's ECG signals, including ambulatory pulse width code, to the remote receiving station via the telephone line.

    Device Description

    Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (Pacemaker Data Transmitter, Model CG-4000) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

    The letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about specific studies, sample sizes for test or training sets, data provenance, or ground truth establishment.
    • Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

    Therefore, I cannot extract the requested information from this document.

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