Device Dossier
Cardiac electrophysiology analysis system
Device Dossier for Cardiac electrophysiology analysis system (Cardiac electrophysiology analysis system, Class IIa, sponsor GE Healthcare). ARTG record,…
- GMDN category: Cardiac electrophysiology analysis system
- Sponsor: GE Healthcare
Intended purpose
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements, which may then be displayed filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.