Device Dossier
Defibrillator/pacemaker
Device Dossier for Defibrillator/pacemaker (Physiologic-monitoring defibrillation system, Class IIb, sponsor Stryker). ARTG record, intended purpose,…
- GMDN category: Physiologic-monitoring defibrillation system
- Sponsor: Stryker
Intended purpose
An external defibrillator intended for use in the hospital, physician’s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a “crash cart” as well as for portable emergency response throughout a hospital. The defibrillator/monitor features include: manual and automated external defibrillation, noninvasive cardiac pacing, electrocardiogram (ECG) monitoring, pulse oximetry (oximeter), synchronized cardioversion, noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring. The defibrillator may also have data recording/printing capabilities.