ELI 380

Device typeElectrocardiograph, professional, multichannel: A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

FDA categoryElectrocardiograph

Device ID00812345026818

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information

Phone888-667-8272

Emailtechsupport@mortara.com