510(k) K210112 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
XChange Device, XChange System
| Applicant | Pneuma Therapeutics, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Jan 30, 2023 |
| Received | Jan 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210112
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.