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510(k) Data Aggregation

    K Number
    K051988
    Device Name
    OXY-SERVE II OXYGEN CONSERVING REGULATOR
    Date Cleared
    2005-09-21

    (61 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPERIOR PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving pressure regulator for ambulatory patients. The Conserving Regulator delivers a prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.
    Device Description
    The Oxy-Serve II Oxygen Conserving Regulator is a high pressure oxygen regulator integrated with a conserving device to deliver oxygen during the inhalation phase of a patients breathing cycle, thereby extending the useful life of an oxygen cylinder. The Oxy-Serve II is constructed of aluminum with brass high pressure chamber components. The device is pneumatic and requires no electrical power source. An indexable control knob selects from 11 flow rates ranging from 1 to 6 LPM in .5 LPM increments. Two outlet ports are connectable using a dual lumen cannula. One port senses the inhalation of the patient thus initiating the selected flow to the patient during the full inhalation cycle. Flow ceases at the end of the inhalation cycle. The second port delivers the oxygen. The device can operate as a conserving regulator, or as a standard continuous flow regulator operable by sliding a switch on the face of the regulator housing. In continuous mode the sensing diaphragm control component is bypassed and a continuous flow of oxygen is delivered at the flow selected by the indexable control knob through the outlet port.
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