510(k) K955816 ยท DYG Catheter, Flow Directed
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2006 | Edwards Lifesciences Llc EDWARDS VIGILANCE MONITORS
(FORMERLY BAXTER VIGILANCE MONITORS)
with software release 5.3 or earlier only. Patient monitor which measures cardiac output.
Models: VG, VGS, VGS1, VGS2, VG2, & IVM. Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.