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510(k) Data Aggregation

    K Number
    K182454
    Device Name
    O2 Concepts Oxlife Independence Model 301-0001
    Manufacturer
    Date Cleared
    2018-12-20

    (104 days)

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

    O2 Concepts LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
    Device Description
    The Oxlife Independence is a portable oxygen concentrator that enables patients requiring supplemental oxygen to be treated in a home environment, in an institutional environment or in a vehicle/mobile environment. The Oxlife Independence utilizes O2 Concepts' Dynamic Network Analysis (DNA) technology to provide equipment performance, location and usage data to O2 Concepts and its customers via cellular and GPS connection. The device delivers 87%-95% pure oxygen to a patient through a standard single lumen nasal cannula. The Independence detects a patient breath and delivers a bolus of oxygen during the inhalation period in pulse mode or delivers a continuous flow of oxygen in continuous mode.
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