510(k) K203131 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 22, 2021 |
| Received | Oct 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203131
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.