510(k) K251674 · MXA System, Test, Breath Nitric Oxide
Fenom Flo FeNO Monitoring System
| Applicant | Mgc Diagnostics Corporation, St. Paul MN, US |
| Decision | Substantially Equivalent, Nov 26, 2025 |
| Received | May 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251674
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.