510(k) K082308 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 9, 2008 |
| Received | Aug 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082308
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.