Device Dossier
Physiologic-monitoring defibrillation system
Device Dossier for Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class IIb, sponsor Emu Medical Group).…
- GMDN category: Physiologic-monitoring defibrillation system
Intended purpose
An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.