510(k) K260880 ยท OLW Index-Generating Electroencephalograph Software
SedLine Sedation Monitor
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 10, 2026 |
| Received | Mar 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260880
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.