BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S053 · Decision Dec 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    LifePulse High Frequency Ventilator
    PMA Number
    P850064
    Supplement Number
    S053
    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 28, 2023
    Date Received
    September 29, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements.

    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