Device Dossier

Cardiac electrophysiology application software

Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIa, sponsor Huawei…

Intended purpose

The ECG app records the user's single-lead ECG, classifies sinus rhythm or atrial fibrillation based on the ECG waveform. Users can share the ECG recordings, rhythm classifications and accompany symptoms with a qualified healthcare professional. The ECG app is intended to be used by people aged 18 years and over.

TGA Public Summary