Device Dossier

Patient monitor, electrocardiograph

Device Dossier for Patient monitor, electrocardiograph (Patient monitor, electrocardiograph, Class IIa, sponsor Ecomed). ARTG record, intended purpose,…

Intended purpose

The device is used to acquire ECG signals from adult and paediatric 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 offered to clinicians on an advisory basis only.

TGA Public Summary