FDA Product Code DPS: Electrocardiograph

FDA product code DPS covers electrocardiographs used for recording the electrical activity of the heart.

These devices capture and display the cardiac electrical cycle as a series of waveforms — P, QRS, and T waves — that provide diagnostic information about heart rate, rhythm, and conduction. ECG recordings are essential in the diagnosis of arrhythmias, myocardial infarction, and other cardiac conditions.

DPS devices are Class II medical devices, regulated under 21 CFR 870.2340 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Ge Medical Systems Information Technologies, Inc., Edan Instruments, Inc. and Masimo Corporation.