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

    NATUS SLEEPWORKS, MODEL 104017

    K Number: K090277 · Decision Apr 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    804

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    Basic Information

    Device Name
    NATUS SLEEPWORKS, MODEL 104017
    K Number
    K090277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Excel-Tech Ltd. (Xltek)
    Date Received
    February 4, 2009
    Decision Date
    April 19, 2011
    Product Code
    OLZ
    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
    OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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