BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Nitric Oxide Generator And Delivery System

    PMA: P200044 · Supplement: S005 · Decision Oct 20, 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
    S005
    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
    October 20, 2023
    Date Received
    September 22, 2023
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a new calibration guide labeling document to provide additional clarification of the calibration instructions provided in the Operator’s Manual

    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