BEUDAMED
    Product Code: MXA FDA class 2 21 CFR 862.3080

    System, Test, Breath Nitric Oxide

    Clinical Toxicology

    A Breath Nitric Oxide Test System is a non-invasive diagnostic device that measures the concentration of fractional exhaled nitric oxide (FeNO) in exhaled breath, used as a biomarker of eosinophilic airway inflammation to aid in the diagnosis and management of asthma and other inflammatory airway conditions. It is FDA Class 2, requiring 510(k) clearance, with product code MXA under 21 CFR 862.3080 in the Clinical Toxicology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    15
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    8
    Years Active
    23

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    Basic Information

    Product Code
    MXA
    Device Class
    FDA class 2
    Regulation Number
    862.3080
    Medical Specialty
    Clinical Toxicology
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 15 510(k) clearances via K numbers.

    K Number Device Name
    K251674 Fenom Flo™ FeNO Monitoring System
    K243926 Vivatmo pro-S
    K233775 Vivatmo pro
    K213611 Fenom Pro
    K203695 NObreath®
    K182874 Fenom Pro Nitric Oxide Test
    K170983 NIOX VERO
    K150233 NIOX VERO Airway Inflammation Monitor
    K133898 NIOX VERO AIRWAY INFLAMMATION MONITOR
    K123683 NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
    K101034 NIOX MINO MODEL 09-1000
    K083617 APIERON INSIGHT ENO SYSTEM
    K073265 APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
    K072816 NIOX MINO
    DEN030001 NIOX ARTICLE NO: 02-1000

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.