bcbef104-8f81-4473-b6da-cd814d205262UpdatePublished22021-03-102020-04-162028-04-15In Commercial DistributionB510ECG121PrimaryHIBCCADVANCED ELECTROCARDIOGRAPHECG-12608736880ADVANCED INSTRUMENTATIONS, INC.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK11180500016231Electrocardiograph, professional, multichannelA 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.falseActiveDPSElectrocardiographfalsefalse