Device Dossier
Cardiac electrophysiology application software
Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor Stark Medical).…
- GMDN category: Cardiac electrophysiology application software
Intended purpose
An Artificial Intelligence software for automated interpretation and diagnosis for ECG and Holter monitoring. Is intended to be used by qualified medical professionals, experienced in examining and evaluating ECG/Holter data as a support to provide relevant clinical information.