Capnostream™35 Portable Respiratory Monitor (PM35MN) is an AI-enabled medical device from Covidien, LLC, listed by FDA (510(k), K253030) with a decision date of 2026-05-01. Review panel: Anesthesiology.
| FDA submission number | K253030 |
|---|---|
| Pathway | 510(k) |
| Company | Covidien, LLC |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2026-05-01 |
| Decision | Substantially Equivalent |
| Product code | CCK |
| Classification | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | 2 |
| Regulation number | 868.1400 |
| Review time (calendar days) | 224 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.