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

    MONOBLOCK PROSTOPERATIVE TENS ELECTRODE

    K Number: K832145 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    MONOBLOCK PROSTOPERATIVE TENS ELECTRODE
    K Number
    K832145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    New Dimensions IN Medicine, Inc.
    Date Received
    July 5, 1983
    Decision Date
    July 19, 1983
    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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