510(k) DEN240062 ยท SEM Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Minder System
| Applicant | Epi-Minder Pty, Ltd., Melbourne, AU |
| Decision | Unknown, Apr 17, 2025 |
| Received | Oct 18, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240062
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.