BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S011 · Decision Dec 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
    PMA Number
    P850064
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    LSZ
    Generic Name
    VENTILATOR, HIGH FREQUENCY
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 18, 1995
    Date Received
    April 5, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPPROVAL FOR AN ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE MODEL 203 LIFE PULSE HIGH FREQUENCY JET VENTILATOR. THE ENDOTRACHEAL TUBE ADAPTOR WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "LIFEPORT" ENDOTRACHEAL TUBE ADAPTER

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LSZ Ventilator, High Frequency