Device Dossier

Physiologic-monitoring defibrillation system

Device Dossier for Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class IIb, sponsor Stryker). ARTG record,…

Intended purpose

An electrical device intended to defibrillate the heart by an electric pulse shock via external or internal electrodes. The defibrillator is equipped with an electrocardiogram (ECG) monitor and a synchronizing capability. The analysis of the ECG and the delivery of the shock is carried out manually by a trained operator.

TGA Public Summary