510(k) K251326 ยท BZQ Monitor, Breathing Frequency
Respiration Rate algorithm
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 11, 2026 |
| Received | Apr 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251326
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.