Device Dossier
Cardiac electrophysiology application software
Device Dossier for Cardiac electrophysiology application software (Cardiac electrophysiology application software, Class IIb, sponsor Ironbark Creek…
- GMDN category: Cardiac electrophysiology application software
Intended purpose
Computerised analysis of cardiac electrical data from ECG leads to detect acute myocardial ischaemic injury including AMI (acute myocardial infarction) for patients presenting with chest pain or presumed ACS (acute coronary syndrome).