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

    CAREFUSION NICOLET EDX

    K Number: K120979 · Decision Apr 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    CAREFUSION NICOLET EDX
    K Number
    K120979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion 209, Inc.
    Date Received
    April 2, 2012
    Decision Date
    April 25, 2012
    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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