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510(k) Data Aggregation

    K Number
    K991424
    Device Name
    INSULSCAN INSULATION TESTING SYSTEM
    Manufacturer
    MEDICOR CORP.
    Date Cleared
    1999-07-22

    (90 days)

    Product Code
    HFG
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.
    Device Description
    The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter, and a ten-foot long connection cable. The InsulScan™ system is powered by a rechargeable battery housed in the control unit. A battery recharger unit and battery charger cable are provided for recharging. The InsulScan™ probe is provided sterile, single use and may not be resterilized.
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