510(k) K060660 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 25, 2006 |
| Received | Mar 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2010 | Edwards Lifesciences, Llc Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001
The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vig Terminated |
DXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.