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
This device is intended as a portable ECG acquisition, analysis and recording system. It is intended to be used under the direct supervision of a licensed healthcare practitioner, and by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices outreach centers. It is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years