BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    DISPOSABLE ADHESIVE SURFACE ELECTRODE

    K Number: K120494 · Decision Jun 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    9
    Review Days
    115

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    Basic Information

    Device Name
    DISPOSABLE ADHESIVE SURFACE ELECTRODE
    K Number
    K120494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spes Medica Srl
    Date Received
    February 17, 2012
    Decision Date
    June 11, 2012
    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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