510(k) K200276 ยท POS Physiological Signal Based Seizure Monitoring System
SPEAC System
| Applicant | Brain Sentinel, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 6, 2021 |
| Received | Feb 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200276
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.