Device Dossier

Multichannel electrocardiograph, interpretive, home-use

Device Dossier for Multichannel electrocardiograph, interpretive, home-use (Multichannel electrocardiograph, interpretive, home-use, Class IIa, sponsor…

Intended purpose

The device is intended to record, store, and transfer one-and two-channel electrocardiogram (ECG) rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, HATIV P30 can record Lead-I. In two channel mode, HATIV P30 can record Lead-I and Lead-II simultaneously. HATIV P30 also displays ECG rhythms and output of ECG analysis including detecting the presence of normal sinus rhythm, atrial fibrillation or flutter, sinus rhythm with VPB, sinus rhythm with APB, bradycardia, and tachycardia.