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