Device typeElectrocardiographic ambulatory recorder: An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
FDA categoryElectrocardiograph, ambulatory (without analysis)
Device IDB632MDB01023
Catalog numberMDB01023
AvailabilityPrescription
MRI safetyMR Unsafe