510(k) K253030 · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Capnostream35 Portable Respiratory Monitor (PM35MN)
| Applicant | Covidien, LLC, Lafayette CO, US |
| Decision | Substantially Equivalent, May 1, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253030
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.