510(k) K203113 ยท OLW Index-Generating Electroencephalograph Software
Masimo SedLine Sedation Monitor and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 25, 2022 |
| Received | Oct 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203113
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.