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510(k) Data Aggregation

    K Number
    K033779
    Device Name
    VIANOX DELIVERY SYSTEM, MODEL II
    Manufacturer
    PULMONOX MEDICAL, INC.
    Date Cleared
    2004-01-26

    (53 days)

    Product Code
    MRN, MRP, MRQ
    Regulation Number
    868.5165
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMONOX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.
    Device Description
    The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/Nz is controlled to maintain a steady concentration of NO/Nz within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/N2 flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern. The device consists of a cart, a gas plumbing connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply. a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.
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    K Number
    K023014
    Device Name
    VIANOX DELIVERY SYSTEM, MODEL I
    Manufacturer
    PULMONOX MEDICAL, INC.
    Date Cleared
    2003-08-14

    (338 days)

    Product Code
    MRP, MRN, MRQ
    Regulation Number
    868.2380
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMONOX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.
    Device Description
    The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/N₂ is controlled to maintain a steady concentration of NO/N₂ within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/Nz flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern. The device consists of a cart, a gas manifold connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply, a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.
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