510(k) K182180 ยท POS Physiological Signal Based Seizure Monitoring System
SPEAC System
| Applicant | Brain Sentinel, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, May 11, 2019 |
| Received | Aug 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182180
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.