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

    NEUROLINK EEG/EP/EMG SURFACE ELECTRODES

    K Number: K942921 · Decision Jan 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    5
    Review Days
    224

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    Basic Information

    Device Name
    NEUROLINK EEG/EP/EMG SURFACE ELECTRODES
    K Number
    K942921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neuro Supplies, Inc.
    Date Received
    June 21, 1994
    Decision Date
    January 31, 1995
    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 Neuro Supplies, Inc.

    K Number Device Name
    K991771 DIGITAL RING ELECTRDE
    K991769 CUTANEOUS (BAR) ELECTRODE
    K991772 CUTANEOUS (DISC) ELECTRODE
    K991770 CUTANEOUS (GROUND) ELECTRODE