510(k) K234021 ยท QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Masimo Stork
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, May 3, 2024 |
| Received | Dec 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234021
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.