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    K Number
    K150930
    Device Name
    Deployable Oxygen Generation System-Smaill (DOGS-S)
    Manufacturer
    AirSep Corporation
    Date Cleared
    2015-12-18

    (256 days)

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

    AirSep Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Deployable Oxygen Generator System - Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.
    Device Description
    The DOGS-S system is a portable battery powered oxygen concentrator that will be operationally used for ground-based medical assemblages, such as the Expeditionary Medical Support (EMEDS), and En-Route Patient Staging System (ERPSS) in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.
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