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510(k) Data Aggregation

    K Number
    K082829
    Device Name
    AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
    Date Cleared
    2008-12-22

    (88 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Product Code :

    OLF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations. peacetime engagement, crisis response and humanitarian relief operations by trained personnel. The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining. This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized. There are no contraindications.
    Device Description
    The AMOGS system is designed to provide supplemental oxygen meeting USP93% requirements using the Pressure Swing Adsorption (PSA) process on the HH-60M MEV AC helicopter. It is comprised of an oxygen concentrator, monitor panel, backup oxygen cylinder and heat exchanger and filter assembly. The AMOGS utilizes engine bleed air and electrical power from the aircraft resources to provide oxygen-enriched breathing gas for medical evacuation applications. The bleed air is conditioned by the heat exchanger and filter assembly and then routed to the concentrator which produces oxygen-enriched breathing gas. The backup oxygen cylinder provides oxygen-enriched breathing gas during periods in which the concentrator is not operating or the peak demand exceeds the concentrator rated capacity. The monitor panel provides operational status of the concentrator and back up cylinder.
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