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510(k) Data Aggregation

    K Number
    K043361
    Device Name
    ACCUHEART ELECTRODE BELT
    Manufacturer
    ADVANCED BIOELECTRIC CORPORATION
    Date Cleared
    2005-03-22

    (105 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED BIOELECTRIC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuHeart™ Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHeart™ Electrode Belt is compatible for use with most ECG instruments on the market.
    Device Description
    The AccuHeart™ Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and a connectorized cable. The electrode assembly contains multiple dry electrodes. The electrodes are positioned against the skin with light pressure, using the elastic chest belt. The AccuHeart™ Electrode Belt is designed to be used without electrolytic gels and without adhesives on unprepared skin, i.e., without the requirements for shaving, abrading or other skin preparations.
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