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510(k) Data Aggregation

    K Number
    K080256
    Device Name
    PULMODYNE CHF FLOW GENERATOR SYSTEM
    Manufacturer
    PULMODYNE
    Date Cleared
    2008-05-09

    (99 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULMODYNE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide CPAP to spontaneously breathing adult patients in the hospital and pre-hospital (EMS) environment.
    Device Description
    The Pulmodyne CHF Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 150 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube. The Pulmodyne CHF Flow Generator incorporates several components: Flow generator (two styles - fixed flow and variable flow) . Patient interface mask . PEEP valve . Circuit / tubing and connectors . Air entrainment filter . The Pulmodyne CHF Flow Generator is multi-patient, reusable and can be cleaned while the other components: circuit, mask, entrainment filter, and PEEP valve are disposable, single patient use.
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