510(k) K203687 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 28, 2021 |
| Received | Dec 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203687
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.