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510(k) Data Aggregation

    K Number
    K030547
    Device Name
    MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
    Manufacturer
    GUARDIAN ANGEL PRODUCTS, INC.
    Date Cleared
    2003-07-11

    (141 days)

    Product Code
    DRL
    Regulation Number
    870.5325
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUARDIAN ANGEL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.
    Device Description
    The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.
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