Device Dossier

Subdermal needle electrode

Device Dossier for Subdermal needle electrode (Subdermal needle electrode, Class IIa, sponsor AMBU). ARTG record, intended purpose, GMDN category —…

Intended purpose

The Ambu Neuroline Subdermal and Twisted Pair Subdermal needle electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are sterile and for single use only