510(k) K213682 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, View
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 22, 2022 |
| Received | Nov 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213682
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.