510(k) K220635 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Heater-Cooler System 3T
| Applicant | Livanova Deutschland, GmbH, Munchen, DE |
| Decision | Substantially Equivalent, Nov 16, 2022 |
| Received | Mar 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220635
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.