Device Dossier

Self-care monitoring web-based application software

Device Dossier for Self-care monitoring web-based application software (Self-care monitoring web-based application software, Class IIa, sponsor J A…

Intended purpose

This medical device software is intended to record and store single-channel electrocardiogram (ECG) rhythms. This medical device software displays ECG rhythms and detects the presence of atrial fibrillation, normal sinus rhythm, bradycardia and tachycardia. This medical device software is intended for use by patients with known or suspected arrhythmia, or health-conscious individuals in a general household situation.

TGA Public Summary