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

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S047 · Decision Mar 31, 2022
    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
    S047
    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
    March 31, 2022
    Date Received
    March 7, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the current Pneumatics Test Fixture that is used to perform in-process performance tests on the Pneumatics Subassembly (HFV 204) to ensure basic functionality and to make rough adjustments prior to installation of this subassembly into the Life PulseHigh Frequency Ventilator.

    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