SEM

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Product code

SEM

Device name

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Device class

Class 2

21 CFR

21 CFR 882.1360

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-06-11.

1 summaries are archived here for direct download.