510(k) DEN190029 ยท QMS Adjunctive Open Loop Fluid Therapy Recommender
Acumen Assisted Fluid Management (AFM) Software Feature
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Unknown, Nov 13, 2020 |
| Received | Jun 3, 2019 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN190029
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.