Device Dossier
Interpretive multichannel electrocardiograph
Device Dossier for Interpretive multichannel electrocardiograph (Interpretive multichannel electrocardiograph, Class IIa, sponsor Compliance Management…
- GMDN category: Interpretive multichannel electrocardiograph
Intended purpose
CardioSecur pro is intended to record, evaluate, document and diagnose a resting ECG of Adults. CardioSecur pro is a medical, electrical system comprising an ECG cable, an iOS device and an app for an iOS device. CardioSecur records a 22-lead ECG using 4 electrodes. Only medically trained personnel may use CardioSecur. When in automatic mode, CardioSecur may also be used by untrained personnel.