Device Category Dossier

Physiologic-monitoring defibrillation system

Device Category Dossier for Physiologic-monitoring defibrillation system. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Defibrillation monitors are electrically-powered assemblies designed to defibrillate the heart, incorporating manual and/or automated external defibrillation capability alongside one or more monitoring and therapeutic features including electrocardiogram monitoring, noninvasive cardiac pacing, cardioversion, pulse oximetry, blood pressure monitoring, and end-tidal carbon dioxide monitoring. These devices are intended for use by trained medical professionals in both in-hospital settings such as emergency rooms and operating rooms, and out-of-hospital environments including emergency medical services vehicles and clinical transport.