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510(k) Data Aggregation

    K Number
    K101606
    Device Name
    MICROMED PD-8K INSULATION DEFECT DETECTOR
    Manufacturer
    MCGAN TECHNOLOGY, LLC
    Date Cleared
    2010-10-01

    (115 days)

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

    MCGAN TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.
    Device Description
    The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable. MicroMed PD-8K System includes: - Detector (base unit) - Battery with Charging adaptor - Probe handle with 2m (6ft) lead-Red HV Wire - 2m (6ft) lead ground wire with clamp-Green Wire - Brush electrode 8mm (0.31inch) wide brass wires - Ring Electrode with brass wires - Carrying case - Standard Operating Instruction manuals. CD With additional information.
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