510(k) K131588 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 22, 2014 |
| Received | May 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131588
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.