510(k) K180881 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, HemoSphere Pressure Cable
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Apr 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180881
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.