510(k) K193179 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
EV1000 Clinical Platform
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 17, 2019 |
| Received | Nov 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193179
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.