510(k) K150272 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Capnostream 35 Portable Respiratory Monitor
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Jul 17, 2015 |
| Received | Feb 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2020 | Covidien Llc Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or Open, Classified |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.