510(k) clearance
Minder® System
- 510(k) number
- K262318
- Applicant
- Epi-Minder Pty, Ltd.
- Decision date
- Oct 29, 2026
- Date received
- Jul 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SEM
- Device type
- Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- Device class
- Class II
- Regulation
- 21 CFR 882.1360
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Melbourne, AU