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

    EnsoSleep

    K Number: K162627 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    192

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    Basic Information

    Device Name
    EnsoSleep
    K Number
    K162627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ensodata, Inc.
    Date Received
    September 20, 2016
    Decision Date
    March 31, 2017
    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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    Other Clearances by Ensodata, Inc.

    K Number Device Name
    K210034 EnsoSleep