510(k) K192058 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
EV1000 Clinical Platform NI, EV1000 Clinical Platform
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | Aug 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192058
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.