MXA
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251674 | 2025-11-26 | Mgc Diagnostics Corporation | Fenom Flo FeNO Monitoring System | |
| K243926 | 2025-09-11 | Bosch Healthcare Solutions GmbH | Vivatmo pro-S | |
| K233775 | 2024-02-22 | Bosch Healthcare Solutions GmbH | Vivatmo pro |
Official FDA classification page: MXA
Classification and pathway per current FDA publications. Data from openFDA (CC0).