510(k) K213273 ยท OLW Index-Generating Electroencephalograph Software
Brain Anesthesia Response Monitor (Bar Monitor)
| Applicant | Cortical Dynamics , Ltd., North Perth, AU |
| Decision | Substantially Equivalent, Sep 1, 2023 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213273
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.