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 to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional. This device is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional’s facility or wherever ECG testing is performed.