510(k) K220533 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Endoscopy Oxygen Mask
| Applicant | Engineered Medical Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 16, 2022 |
| Received | Feb 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220533
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.