510(k) K233984 ยท QMS Adjunctive Open Loop Fluid Therapy Recommender
Acumen Assisted Fluid Management (AFM) Software Feature
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 2, 2024 |
| Received | Dec 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233984
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.