510(k) K103094 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 17, 2011 |
| Received | Oct 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103094
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.