Device Dossier

Telemetry system transmitter, electrocardiograph

Device Dossier for Telemetry system transmitter, electrocardiograph (Telemetry system transmitter, electrocardiograph, Class IIa, sponsor GE Healthcare).…

Intended purpose

This ECG device is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in adults and paediatric populations in the following cases: •Patients with suspected cardiac abnormalities •Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired.

TGA Public Summary