BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NARCOTREND, MODEL COMPACT 4.0

    K Number: K033543 · Decision Sep 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    312

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    Basic Information

    Device Name
    NARCOTREND, MODEL COMPACT 4.0
    K Number
    K033543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mt Monitortechnik GmbH & Co. KG
    Date Received
    November 10, 2003
    Decision Date
    September 17, 2004
    Product Code
    OLW
    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
    OLW Index-Generating Electroencephalograph Software

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