Patient data recorder, long-term, electrocardiograph

Intended purpose

Intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods of up to 48-hours for a minimum 24-hour period. The Holter System is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm, and arrhythmia