510(k) K062134 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 22, 2006 |
| Received | Jul 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062134
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.