510(k) K213611 ยท MXA System, Test, Breath Nitric Oxide
Fenom Pro
| Applicant | Caire Diagnostics, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jun 7, 2023 |
| Received | Nov 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213611
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.