Compliance Consultants worked on cardiographic catheters and mapping systems that map the interteior surfaces of beating heart. Maps the electrical activity of interior heart surfaces are displayed as 3D data using computer diagnostic software. Used in monomorphic, stationary atrial and ventricular arrhythmias. This device detects and displays cardiac depolarization events from acquired electrophysiological data.


Regulation Number: 21 CFR 870.1425, Product Code: DQK and Regulation Number: 21 CFR 870.1875, Product Code: DQD.