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    K Number
    K071828
    Device Name
    LULLABY
    Manufacturer
    GE HEALTHCARE CLINICAL SYSTEMS
    Date Cleared
    2007-08-06

    (34 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE HEALTHCARE CLINICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.
    Device Description
    The Lullaby™ Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device consists of a freestanding lamp that delivers specific wavelength light to the patient positioned below the lamp.
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