Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102750
    Device Name
    O2-IN-A-BOX, O2-IN-A-BOX
    Manufacturer
    Date Cleared
    2011-02-11

    (141 days)

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

    GETO2, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Emergency Use - OTC: Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed. Rx use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician. Environment of use – Home, institutional, travel / mobile environments.
    Device Description
    A portable oxygen generator that utilizes a chemical reaction to generate oxygen. It is available in two versions: Emergency Use - OTC and Rx use. The Emergency Use version provides a minimum flow rate of 6 LPM for at least 15 minutes with a total oxygen capacity of 90 liters. The Rx use version provides variable flow rates (0.5 LPM for 60 minutes/30 liters capacity and 3 LPM for 30 minutes/90 liters capacity) as prescribed by a physician. Both versions are single use and disposable and use a standard oxygen mask or nasal cannula for patient interface.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1