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510(k) Data Aggregation

    K Number
    K040853
    Device Name
    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
    Manufacturer
    INTERNATIONAL HOSPITAL SUPPLY CO.
    Date Cleared
    2004-06-21

    (81 days)

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

    INTERNATIONAL HOSPITAL SUPPLY CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.
    Device Description
    Not Found
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    K Number
    K033040
    Device Name
    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
    Manufacturer
    INTERNATIONAL HOSPITAL SUPPLY CO.
    Date Cleared
    2003-12-17

    (79 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL HOSPITAL SUPPLY CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care.
    Device Description
    The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat.
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