DEN240062 is an FDA 510(k) submission for the Minder System. This device is classified as a Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring (Class II - Special Controls, product code SEM).
Submitted by Epi-Minder Pty, Ltd. (Melbourne, AU). The FDA issued a Not Cleared (DENG) decision on April 17, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1360. A Sub-scalp Implanted Electroencephalogram (eeg) System For Remote Patient Monitoring Is A Prescription Device Used For Continuously Acquiring, Transmitting, And Storing Electrical Brain Activity Of Patients With Epilepsy. The Device Consists Of Sub-scalp Implanted Electrodes That Are Connected To A Transmitter Or Storage Device. The Device Is Used To Aid Clinicians In The Remote Monitoring Of Electrical Activity In The Patients Brain. The Device Is Not Intended To Be Implanted In Brain Tissue..
| 510(k) Number | DEN240062 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 18, 2024 |
| Decision Date | April 17, 2025 |
| Days to Decision | 181 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SEM - Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1360 |
| Definition | A Sub-scalp Implanted Electroencephalogram (eeg) System For Remote Patient Monitoring Is A Prescription Device Used For Continuously Acquiring, Transmitting, And Storing Electrical Brain Activity Of Patients With Epilepsy. The Device Consists Of Sub-scalp Implanted Electrodes That Are Connected To A Transmitter Or Storage Device. The Device Is Used To Aid Clinicians In The Remote Monitoring Of Electrical Activity In The Patients Brain. The Device Is Not Intended To Be Implanted In Brain Tissue. |