510(k) K110597 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
EV1000 CLINICAL PLATFORM
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 14, 2011 |
| Received | Mar 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110597
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.