Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor GE Healthcare). ARTG…
- GMDN category: Interpretive multichannel electrocardiograph
- Sponsor: GE Healthcare
Intended purpose
The CardioSoft V7.0 is designed to acquire, process, record, archive, analyze and output (12 and 15 lead suction) data during a period of physiologic stress or during a resting ECG test and acquire data from ancillary devices, such as spirometry and ambulatory blood pressure devices Cardiosoft Cardiac Testing System V7.0 use is intended for trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.