Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor Intermed Medical). ARTG…
- GMDN category: Interpretive multichannel electrocardiograph
- Sponsor: Intermed Medical
Intended purpose
The device is an electrocardiograph intended to be used by trained operators under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis of cardiovascular diseases in adult and paediatric patients at rest or undergoing exercise stress testing.