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 Edwards Lifesciences, LLC, Abbott Medical and Biosense Webster, Inc..
List of Computer, Diagnostic, Programmable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Computer, Diagnostic, Programmable devices (product code DQK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →