510(k) K221373 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Essenz HLM
| Applicant | Livanova Deutschland, GmbH, Munich, DE |
| Decision | Substantially Equivalent, Mar 9, 2023 |
| Received | May 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221373
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.