Device Dossier
Electrocardiograph, Holter analyser, software
Device Dossier for Electrocardiograph, Holter analyser, software (Electrocardiograph, Holter analyser, software, Class IIa, sponsor Life Systems…
- GMDN category: Electrocardiograph, Holter analyser, software
Intended purpose
Medical software to perform automated beat and rhythm analysis of 1-12 leads ECGs. The software can handle varying levels of signal quality, ranging from the simplified ECGs from single lead recordings with low powered mobile devices, to high-quality 12 lead recordings. The software is not a complete diagnostic ECG software, and it is neither intended for real-time applications, nor for interpretation of all types of life-threatening cardiac diseases.