BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P890057 · Supplement: S029 · Decision Jul 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
    PMA Number
    P890057
    Supplement Number
    S029
    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
    July 23, 2025
    Date Received
    April 23, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    for a change in the raw material base resin for the 772722-102 pressure sense line Flex, circuit 71.0 LG, used in the 3100 Series Ventilators Patient Circuit connectors.

    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