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510(k) Data Aggregation

    K Number
    DEN140032
    Device Name
    Cereve Sleep System
    Manufacturer
    CEREVE, INC.
    Date Cleared
    2016-05-13

    (571 days)

    Product Code
    PLU
    Regulation Number
    882.5700
    Why did this record match?
    Product Code :

    PLU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cerêve Sleep System is indicated to reduce sleep latency to Stage 1 and Stage 2 sleep in patients with primary insomnia.
    Device Description
    The Cereve Sleep System is a cooling device comprised of three components: the bedside unit, the forehead pad, and headgear. The device pumps chilled fluid through the forehead pad, at patient selectable temperatures in a narrow range between 14 and 16 °C.
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