BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P890057 · Supplement: S027 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator
    PMA Number
    P890057
    Supplement Number
    S027
    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
    November 15, 2024
    Date Received
    July 3, 2023
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The material change made to a component on 3100 HFOV pressure sense line as part of the patient circuit has been reviewed and is acceptable.

    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