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    K Number
    K031096
    Device Name
    MODIFICATION TO TRANSPORT INCUBATOR 185
    Manufacturer
    INTERNATIONAL BIOMEDICS, INC.
    Date Cleared
    2003-06-24

    (78 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BIOMEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.
    Device Description
    The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.
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