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

    CDSA(COLOR DENSITY, SPECTRAL ARRRAY)

    K Number: K852587 · Decision Aug 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    10
    Review Days
    59

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    Basic Information

    Device Name
    CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
    K Number
    K852587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Northern, Inc.
    Date Received
    June 18, 1985
    Decision Date
    August 16, 1985
    Product Code
    OLT
    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
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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    Other Clearances by Tracor Northern, Inc.

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    K850109 NOMAD TM-3400
    K842964 PHOTIC STIMULATOR TM-3030-70
    K832084 EVOKED 3500 POTENTIAL SYSTEM
    K822396 THE 3500
    K810560 TN-3000 EVOKED RESPONSE SYSTEM