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510(k) Data Aggregation

    K Number
    K100920
    Device Name
    MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
    Date Cleared
    2010-11-29

    (241 days)

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

    SEQUAL TECHNOLOGIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SeQual Model T2000 Series, MESA II Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities. The device has no contraindications. The MESA II Oxygen Concentrator (Model No.: T2000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.
    Device Description
    The SeQual Model T2000 Series, MESA II Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen. The SeQual Model T2000 Series, MESA II Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
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    K Number
    K091541
    Device Name
    MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES
    Date Cleared
    2009-12-31

    (219 days)

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

    SEQUAL TECHNOLOGIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MESA Oxygen Concentrator (Model No .: 2-6000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.
    Device Description
    The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is a 0.5 to 5.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen. The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.
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