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

    THE 3500

    K Number: K822396 · Decision Sep 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    10
    Review Days
    45

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    Basic Information

    Device Name
    THE 3500
    K Number
    K822396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Northern, Inc.
    Date Received
    August 10, 1982
    Decision Date
    September 24, 1982
    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.

    K Number Device Name
    K883340 NEURAL MAGNETIC STIMULATOR, THE D190
    K874733 GUARDIAN, EEG BRAIN MONITORING SYSTEM
    K860968 TM-3400, NOMAD (MODIFIED)
    K860903 TM-3600 A NEURODIAGNOSTIC SYSTEM
    K852587 CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
    K850109 NOMAD TM-3400
    K842964 PHOTIC STIMULATOR TM-3030-70
    K832084 EVOKED 3500 POTENTIAL SYSTEM
    K810560 TN-3000 EVOKED RESPONSE SYSTEM