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

    TM-3400, NOMAD (MODIFIED)

    K Number: K860968 · Decision Aug 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    10
    Review Days
    160

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    Basic Information

    Device Name
    TM-3400, NOMAD (MODIFIED)
    K Number
    K860968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Northern, Inc.
    Date Received
    March 11, 1986
    Decision Date
    August 18, 1986
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by Tracor Northern, Inc.

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    K832084 EVOKED 3500 POTENTIAL SYSTEM
    K822396 THE 3500
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