510(k) K100709 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 7, 2010 |
| Received | Mar 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100709
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.