BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Nitric Oxide Generator And Delivery System

    PMA: P200044 · Supplement: S004 · Decision Sep 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Nitric Oxide Generator And Delivery System
    Trade Name
    LungFit PH
    PMA Number
    P200044
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QTB
    Generic Name
    Nitric Oxide Generator and Delivery System
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 29, 2023
    Date Received
    June 30, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a minor hardware change to allow the user to increase the alarm volume by moving a mechanical slider on the backside of the LungFit PH display.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QTB Nitric Oxide Generator And Delivery System