510(k) K211465 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
| Applicant | Edwards Lfesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 8, 2021 |
| Received | May 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211465
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.