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

    INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES

    K Number: K891105 · 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 MODEL 4X4 SP ELECTRODE STIM. PATCHES
    K Number
    K891105
    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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    Other Clearances by Acudata Software

    K Number Device Name
    K900596 ACUDATA INDICATENS MODEL 5A
    K900668 ACUDATA INDICATENS MODEL 5XS
    K890087 ACUDATA INDICATENS MODEL 5M
    K890088 ACUDATA INDICATENS MODEL 5X
    K891107 INDICATENS INDICATOR ELECTRODE MODEL 2
    K881708 INDICATENS 4X4