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

    STIMULATOR, TN-3001 SOMATOSENSORY

    K Number: K781704 · Decision Dec 1, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    10
    Review Days
    52

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    Basic Information

    Device Name
    STIMULATOR, TN-3001 SOMATOSENSORY
    K Number
    K781704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Instruments, Inc.
    Date Received
    October 10, 1978
    Decision Date
    December 1, 1978
    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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