BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    DISPOSABLE ELECTRODE

    K Number: K111737 · Decision Oct 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    DISPOSABLE ELECTRODE
    K Number
    K111737
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sanibel Supply
    Date Received
    June 21, 2011
    Decision Date
    October 14, 2011
    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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