510(k) K202621 ยท OLW Index-Generating Electroencephalograph Software
NeuroSENSE Monitoring System, Model NS-901
| Applicant | Neurowave Systems, Inc., Cleveland Heights OH, US |
| Decision | Substantially Equivalent, Aug 5, 2021 |
| Received | Sep 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202621
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.