BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P850064 · Supplement: S052 · Decision Jun 21, 2024
    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
    S052
    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
    June 21, 2024
    Date Received
    July 12, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The site was inspected in April 2024 and the EIR recommendation was VAI. Review of the report and the Firm's response were provided. The recommendation for the inspection is VAI.

    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