510(k) K203695 · MXA System, Test, Breath Nitric Oxide
NObreath®
| Applicant | Bedfont Scientific, Ltd., Maidstone, Kent, GB |
| Decision | Substantially Equivalent, Dec 17, 2021 |
| Received | Dec 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203695
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.