510(k) DEN240062
- Device
- Minder System
- Applicant
- Epi-Minder Pty, Ltd.
- 510(k) number
- DEN240062
- Product code
- SEM
- Decision
- Unknown (DENG)
- Decision date
- 2025-04-17
- Date received
- 2024-10-18
- Regulation
- 882.1360
- Classification name
- Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tracy Cameron
- Address
- 384-388 Albert St. Melbourne AU 3002 3002
FDA Registration Numbers#
- 3039411139
- 3009092818
- 3039640505
- 3002806740
Source Documents#
510(k) summary PDF not indicated by FDA