Device Dossier

Electroencephalograph

Device Dossier for Electroencephalograph (Electroencephalograph, Class IIa, sponsor Compumedics). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

The Grael EEG System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or neurological disorders. The Grael EEG System is designed for use in a hospital or other clinical environment. The Grael EEG System is only to be used under the direction of a physician. The Grael EEG System is comprised of hardware and software which, depending on the model type, provides up to 60 separate parameters for recording, review and analysis.

TGA Public Summary