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

    PHOTIC STIMULATOR TM-3030-70

    K Number: K842964 · Decision Dec 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    PHOTIC STIMULATOR TM-3030-70
    K Number
    K842964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Northern, Inc.
    Date Received
    July 27, 1984
    Decision Date
    December 28, 1984
    Product Code
    GWE
    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
    GWE Stimulator, Photic, Evoked Response

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    Other Clearances by Tracor Northern, Inc.

    K Number Device Name
    K883340 NEURAL MAGNETIC STIMULATOR, THE D190
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    K860903 TM-3600 A NEURODIAGNOSTIC SYSTEM
    K852587 CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
    K850109 NOMAD TM-3400
    K832084 EVOKED 3500 POTENTIAL SYSTEM
    K822396 THE 3500
    K810560 TN-3000 EVOKED RESPONSE SYSTEM