BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)

    K Number: K082829 · Decision Dec 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    88

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    Basic Information

    Device Name
    AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
    K Number
    K082829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carleton Life Support Systems, Inc.
    Date Received
    September 25, 2008
    Decision Date
    December 22, 2008
    Product Code
    OLF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Expedited Review
    Y
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLF Medevac Use Oxygen Generator

    Other Clearances by Carleton Life Support Systems, Inc.

    K Number Device Name
    K071904 DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
    K051887 PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)