510(k) K260907 · OLW Index-Generating Electroencephalograph Software
BIS Advance pEEG Module
| Applicant | Covidien LP, Mansfield MA, US |
| Decision | Substantially Equivalent, Aug 13, 2026 |
| Received | Mar 19, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260907
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.