510(k) K160552 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 1, 2016 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2019 | Edwards Lifesciences, LLC EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS
Product Usage:
EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sen Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.