SEM — Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring Class II
FDA product code SEM covers "Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring", a Class II medical device regulated under 21 CFR 882.1360. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SEM
- Device Class
- Class II
- Regulation Number
- 882.1360
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
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.