510(k) K223865 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 9, 2023 |
| Received | Dec 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223865
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.