510(k) K140312 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Feb 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2015 | Edwards Lifesciences, LLC ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.