BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S038 · Decision Nov 19, 2018
    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
    S038
    Device Class
    FDA Class 3
    Product Code
    LSZ
    Generic Name
    VENTILATOR, HIGH FREQUENCY
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 19, 2018
    Date Received
    October 25, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding an additional supplier of the Patient Box standoffs that are used in both models of the Patient Box (312 and 314). The change proposed does not affect the performance of the Patient Box and thus the LifePulse High Frequency Ventilator is not affected. There is no change to the design or any labeling. The following manufacturing facility is affected by the change(s): Bunnell Incorporated, 436 Lawndale Drive, Salt Lake City, Utah.

    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