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

    INDICATENS INDICATOR ELECTRODE MODEL 2

    K Number: K891107 · Decision May 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    INDICATENS INDICATOR ELECTRODE MODEL 2
    K Number
    K891107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Acudata Software
    Date Received
    March 2, 1989
    Decision Date
    May 25, 1989
    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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