510(k) K232294 · DQK Computer, Diagnostic, Programmable
HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 31, 2023 |
| Received | Aug 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232294
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.