Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
SEM · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1360
Classification
FDA Product Code
SEM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1360
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.