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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?
    Applicant Name (Manufacturer) :

    CARLETON LIFE SUPPORT SYSTEMS INC.

    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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    K Number
    K071904
    Device Name
    DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
    Date Cleared
    2007-10-25

    (107 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARLETON LIFE SUPPORT SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DOGS-M system is intended to provide supplemental oxygen enriched gas to patients who may have difficulty extracting oxygen from air that they breathe. 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 military personnel. The DOGS-M has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOGS-M system or to fill cylinders for patient ambulatory use. The oxygen supplied by the DOGS-M 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 Deployable Oxygen Generation System – Medium (DOGS-M) is a point of use oxygen generation system designed to meet the needs of the Air Force for ground based medical support. The DOGS-M consists of an oxygen generation system, a low pressure oxygen compressor, high pressure oxygen compressor, cylinder evacuation pump and integral back up oxygen storage cylinders in a single module. The oxygen generation system uses an integral air compressor and Pressure Swing Adsorption (PSA) technology to separate up to 120 liters per minute of oxygen meeting the requirements of USP93% from ambient air. The high pressure compressor is designed to charge cylinders to 2250 psig at approximately 60 liters per minute. To insure that there are no contaminants in the cylinders prior to filling, the system is provided with an evacuation pump that can evacuate an H cylinder down to 25 inches mercury in less than 10 minutes.
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    K Number
    K051887
    Device Name
    PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
    Date Cleared
    2005-09-27

    (77 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARLETON LIFE SUPPORT SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PVOCS HF system is intended to provide respiratory gases to include pre and post operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use. It is appropriate for use by military personnel only.
    Device Description
    The PVOCS HF is a dual-mode medical gas system which supplies both oxygen-enriched gas at 93 ± 3% oxygen (hereafter referred to as OXY 93% or USP Oxygen 93%) and medical-grade air (MED AIR). In the High Flow OXY 93% mode, the PVOCS HF can supply up to 30 lpm of oxygen and 30 lpm of medical-grade air, and in the Low Flow OXY 93% mode oxygen mode, up to 20 lpm of oxygen and 75 lpm of medical-grade air. The system requires a separate compressed air supply from which oxygen is concentrated using pressure swing adsorption (PSA) techniques with synthetic zeolite. The oxygen is supplied at two low-pressure (6-psig) ports for patient respiration via nasal cannula and four moderate-pressure (50-psig) ports for patient ventilators. A storage plenum (purge tank) is included in the product line to ensure that short-term, high-demand flows do not cause a drop in oxygen concentration or pressure drops below rated output pressure in the product gas. The medical-grade air is provided to four ports at 50 psig by filtering the compressed air supply and drying it using PSA techniques.
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