BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P890057 · Supplement: S009 · Decision Jul 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
    PMA Number
    P890057
    Supplement Number
    S009
    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
    July 8, 1997
    Date Received
    May 16, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.

    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