Device type

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Product code SEM · Class II · 21 CFR 882.1360 · Neurology

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 patient’s brain. The device is not intended to be implanted in brain tissue.

FDA classification database