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510(k) Data Aggregation

    K Number
    K250805

    Validate with FDA (Live)

    Device Name
    DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
    Manufacturer
    Devilbiss Healthcare, LLC
    Date Cleared
    2025-12-09

    (267 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    K230969
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Devilbiss PulmO2 10-Liter Oxygen Concentrator is intended to provide supplemental oxygen to adult and pediatric patients >10kg requiring oxygen therapy. The device may be used in the home or an institutional setting. The device is not intended to be life sustaining or life supporting.

    Device Description

    The DeVilbiss PulmO2 10-Liter Oxygen Concentrator is a device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen through a pressure swing adsorption process, allowing oxygen to be delivered at a range of prescribed flows to patients in need of supplemental oxygen. The device is housed in a green cabinet.

    AI/ML Overview

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