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

    IEEG

    K Number: K131944 · Decision Apr 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    287

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    Basic Information

    Device Name
    IEEG
    K Number
    K131944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jordan Neuroscience, Inc.
    Date Received
    June 27, 2013
    Decision Date
    April 10, 2014
    Product Code
    OMC
    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
    OMC Reduced- Montage Standard Electroencephalograph

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    Other Clearances by Jordan Neuroscience, Inc.

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