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    K Number
    K131196
    Device Name
    INFANT PHOTOTHERAPY BILITRON SKY 5006
    Manufacturer
    FANEM LDA
    Date Cleared
    2014-02-20

    (300 days)

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

    FANEM LDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fanem Infant Phototherapy Bilitron Sky 5006 is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.
    Device Description
    The Fanem Infant Phototherapy Billtron Sky 5006 is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. They system can be used for infants in bassinets, incubators, open beds or radiant warmers. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum. The Infant Phototherapy Bilitron Sky 5006 consists of a lamp unit and can be hood mounted or trolley mounted.
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