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510(k) Data Aggregation

    K Number
    K052396
    Device Name
    OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
    Manufacturer
    OXYSURE SYSTEMS, INC.
    Date Cleared
    2005-12-09

    (100 days)

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

    OXYSURE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OxySure™ System is intended to produce oxygen for emergency use.
    Device Description
    The OxySure™ System creates medically pure [USP] oxygen at an average flow rate of 6.5 liters per minute for 15 minutes from a catalytic reaction of dry compounds. The OxySure 1 System is comprised of an outer housing, self-contained disposable cartridges that house the dry compounds and water, and a single-use mask and tubing system to deliver the oxygen to the user.
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