Device Dossier
Multichannel electrocardiograph, interpretive, home-use
Device Dossier for Multichannel electrocardiograph, interpretive, home-use (Multichannel electrocardiograph, interpretive, home-use, Class IIa, sponsor…
- GMDN category: Multichannel electrocardiograph, interpretive, home-use
Intended purpose
The product is a small hand-held device that is pressed against the chest for simultaneous recordings of ECG and heart sounds through electrodes and a stethoscope membrane. It is intended for use by healthcare professionals or individuals with known or suspected heart conditions and health conscious individuals. It is not intended for use for vital monitoring as in intensive care.