510(k) K200594 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Capnostream 35 Portable Respiratory Monitor
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Apr 27, 2020 |
| Received | Mar 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200594
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.