BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROMED PD-8K INSULATION DEFECT DETECTOR

    K Number: K101606 · Decision Oct 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    MICROMED PD-8K INSULATION DEFECT DETECTOR
    K Number
    K101606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mcgan Technology, LLC
    Date Received
    June 8, 2010
    Decision Date
    October 1, 2010
    Product Code
    HFG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

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