Device Dossier
Electrocardiograph, general-purpose
Device Dossier for Electrocardiograph, general-purpose (Electrocardiograph, general-purpose, Class IIa, sponsor Device Technologies). ARTG record,…
- GMDN category: Electrocardiograph, general-purpose
- Sponsor: Device Technologies
Intended purpose
The device is used to acquire ECG signals from adult and pediatric patients, for example in stress exercise testing, through body surface ECG electrodes. The electrocardiograph is intended to be used in hospitals and healthcare facilities to help analyse and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only to be used on adult patients and is offered to clinicians on an advisory basis only.