BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    NATUS NEUROWORKS, MODEL 104196

    K Number: K090019 · Decision Feb 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    40
    Applicant Total
    12
    Review Days
    416

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    Basic Information

    Device Name
    NATUS NEUROWORKS, MODEL 104196
    K Number
    K090019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Natus Medical, Inc.
    Date Received
    January 2, 2009
    Decision Date
    February 22, 2010
    Product Code
    OMB
    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
    OMB Automatic Event Detection Software For Full-Montage Electroencephalograph

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