BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventilator, High Frequency

    PMA: P890057 · Supplement: S014 · Decision Sep 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Ventilator, High Frequency
    Trade Name
    MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
    PMA Number
    P890057
    Supplement Number
    S014
    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
    September 24, 2001
    Date Received
    February 22, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0520

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 3100B HFOV. THE DEVICE IS INDICATED FOR USE IN THE VENTILATORY SUPPORT AND TREATMENT OF SELECTED PATIENTS 35 KILOGRAMS AND GREATER WITH ACUTE RESPIRATORY FAILURE.

    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