FDA Product Code DQK: Computer, Diagnostic, Programmable

FDA product code DQK covers programmable diagnostic computers used in cardiovascular medicine.

These systems acquire, process, and analyze cardiovascular signals — including ECG, hemodynamic data, and intracardiac electrograms — to support diagnosis and treatment decisions. They are used in cardiac catheterization labs, electrophysiology suites, and intensive care units.

DQK devices are Class II medical devices, regulated under 21 CFR 870.1425 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Abbott Medical, Edwards Lifesciences, LLC and Biosense Webster, Inc..