Device Dossier
Electrocardiographic long-term ambulatory recorder, telemetric
Device Dossier for Electrocardiographic long-term ambulatory recorder, telemetric (Electrocardiographic long-term ambulatory recorder, telemetric, Class…
Intended purpose
The device is a battery-powered, body-worn instrument intended for continuous recording and electrocardiographic (ECG) data while the patient is performing daily activities. It is designed to record cardiac data for diagnosing cardiac arrhythmias and other ST-segment changes over a long-term period (typically 24 hours or more). The cardiac data captured can be transmitted for clinical review and analysis by healthcare professionals to assist in the diagnosis of cardiac conditions.