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

    GUARDIAN 150 ELECTRODE

    K Number: K083756 · Decision Jun 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    7
    Review Days
    191

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    Basic Information

    Device Name
    GUARDIAN 150 ELECTRODE
    K Number
    K083756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Selectivemed Components, Inc.
    Date Received
    December 17, 2008
    Decision Date
    June 26, 2009
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXY Electrode, Cutaneous

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    Other Clearances by Selectivemed Components, Inc.

    K Number Device Name
    K120922 GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
    K031053 SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
    K020476 MEDION 6000
    K993081 IO-DRIVE
    K946230 ENDURA REUSABLE TENS AND NMES ELECTRODES
    K945676 GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES