510(k) K221833 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 7, 2022 |
| Received | Jun 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221833
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.