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

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S050 · Decision May 31, 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
    S050
    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
    May 31, 2023
    Date Received
    May 10, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Replace the Thermistor Inspection Fixtures with an upgraded design. This change would increase the ease and efficiency of performing incoming inspections of the 3” thermistors (P/N 00234) and 58” thermistors (P/N 00235) which are components in the Patient Circuit used in the LifePulse HFV Systems. The new Inspection Fixtures will not affect the safety or effectiveness of the Patient Circuit or the LifePulse HFV.

    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