510(k) K040287 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 26, 2004 |
| Received | Feb 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040287
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.