BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Nitric Oxide Generator And Delivery System

    PMA: P200044 · Supplement: S013 · Decision Mar 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Nitric Oxide Generator And Delivery System
    Trade Name
    LungFit PH
    PMA Number
    P200044
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    QTB
    Generic Name
    Nitric Oxide Generator and Delivery System
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 13, 2026
    Date Received
    February 12, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of additional in-process tests for PCBA inspection

    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