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510(k) Data Aggregation

    K Number
    K033863
    Device Name
    OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03
    Manufacturer
    OX-GEN INC.
    Date Cleared
    2005-08-22

    (619 days)

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

    OX-GEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is intended to produce instant, non-pressurized oxygen for emergency uses.
    Device Description
    The OX-GEN Rigid O2 Generation System, Model 5-OX-03 is found to be substantially equivalent in that it produces a minimum of 6 liters per minute of 99% pure oxygen for a 15 minute interval, by means of a chemical reaction. The OX-GEN Rigid O2 Generation System is composed of three self-contained chambers that when opened are activated and begin to generate instant, non-pressurized oxygen. The second part of the device consists of the plastic tubing, an inline filter and an oxygen mask, which are attached to the outlet of the oxygen generator.
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