510(k) K230919 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Acumen IQ finger cuff
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 24, 2023 |
| Received | Apr 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230919
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.