BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NICOLET BEAM II SYSTEM

    K Number: K894629 · Decision Mar 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    14
    Applicant Total
    13
    Review Days
    228

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    Basic Information

    Device Name
    NICOLET BEAM II SYSTEM
    K Number
    K894629
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1420
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nicolet Instrument Corp.
    Date Received
    July 24, 1989
    Decision Date
    March 9, 1990
    Product Code
    GWS
    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
    GWS Analyzer, Spectrum, Electroencephalogram Signal

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