Device Dossier
Cardiac catheterization monitoring system
Device Dossier for Cardiac catheterization monitoring system (Cardiac catheterization monitoring system, Class IIa, sponsor GE Healthcare). ARTG record,…
- GMDN category: Cardiac catheterization monitoring system
- Sponsor: GE Healthcare
Intended purpose
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic 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.