510(k) K043103 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 9, 2004 |
| Received | Nov 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2012 | Edwards Lifesciences, Llc Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69,
00.71, 00.73.
Product Usage:
The Vigilance II CCO/SvO2/CEDV Monitor is indicated for Terminated |
DXG | None listed |
| Nov 24, 2007 | Edwards Lifesciences, Llc Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifescien Terminated |
DXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.