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510(k) Data Aggregation

    K Number
    K083163
    Device Name
    OMNI 2 OXYGEN SYSTEM
    Manufacturer
    SEQUAL TECHNOLOGIES, INC.
    Date Cleared
    2009-10-20

    (358 days)

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

    SEQUAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The OMNI 2 Oxygen System is an oxygen concentrator that provides up to 3 LPM continuous flow or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter). The OMNI 2 Oxygen System is based on pressure swing adsorption (PSA) principles. The OMNI 2 Oxygen System operates from AC power, DC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start if inhalation is detected. The OMNI 2 Oxygen System consists of pneumatic and electrical components, AC power supplies, DC cables and lithium ion batteries. The system has inlet filtration, air compressors, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.
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    K Number
    K042262
    Device Name
    INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
    Manufacturer
    SEQUAL TECHNOLOGIES, INC.
    Date Cleared
    2004-09-10

    (18 days)

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

    SEQUAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SeQual Model 6323A-OM-10, Integra 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.
    Device Description
    The SeQual Model 6323A-OM-10, Integra 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 6323A-OM-10, Integra 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
    K013931
    Device Name
    OMNI OXYGEN SYSTEM, MODEL 1000
    Manufacturer
    SEQUAL TECHNOLOGIES, INC.
    Date Cleared
    2002-03-27

    (119 days)

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

    SEQUAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    The SeQual Model Number 1000 OMNI Portable Oxygen Concentrator is a 3 Liter per minute (LPM) continuous flow and 6 LPM demand flow oxygen concentrator that is of the pressure swing adsorption (PSA) type. The OMNI Portable Oxygen Concentrator operates from AC power, DC power or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. The Model Number 1000, OMNI Portable Oxygen System consists of pneumatic and electrical components. The system has 5 major pneumatic components: inlet filtration, air compressor and heat exchanger, Synthetic Zeolite molecular sieve beds with a distribution valve module, outlet filtration, and flow delivery and measurement components. The electrical system consists of: motor controls, power sources for AC and DC power, rechargeable batteries, sensing systems to measure pressure, temperature, flow and oxygen concentration, and a software controlled user interface. The unit is double insulated and uses a two-conductor power cable. In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down. Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures.
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    K Number
    K003472
    Device Name
    INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
    Manufacturer
    SEQUAL TECHNOLOGIES, INC.
    Date Cleared
    2001-06-04

    (208 days)

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

    SEQUAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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