MXA

System, Test, Breath Nitric Oxide

Product code
MXA
Device name
System, Test, Breath Nitric Oxide
Device class
Class 2
21 CFR
21 CFR 862.3080
Medical specialty
Clinical Toxicology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
15 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-11-26.

NumberDecision dateApplicantDevice nameSummary
K2516742025-11-26Mgc Diagnostics CorporationFenom Flo™ FeNO Monitoring SystemPDF
K2439262025-09-11Bosch Healthcare Solutions GmbHVivatmo pro-SPDF
K2337752024-02-22Bosch Healthcare Solutions GmbHVivatmo proPDF

3 summaries are archived here for direct download.

Official FDA classification page: MXA
Classification and pathway per current FDA publications. Data from openFDA (CC0).