DEN240062
- 510(k) number
- DEN240062
- Device name
- Minder System
- Applicant
- Epi-Minder Pty, Ltd. AU
- Product code
- SEM — Sub-Scalp Implanted Electroencephalogram System For
- Decision date
- 2025-04-17
- Date received
- 2024-10-18
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN240062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.