510(k) K243926 ยท MXA System, Test, Breath Nitric Oxide
Vivatmo pro-S
| Applicant | Bosch Healthcare Solutions GmbH, Waiblingen, DE |
| Decision | Substantially Equivalent, Sep 11, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243926
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.