FDA Product Code DQA: Oximeter

Continuous oxygen saturation monitoring is a cornerstone of safe patient care across clinical settings. FDA product code DQA covers pulse oximeters and oximeter systems.

These devices use near-infrared light to non-invasively measure the oxygen saturation of hemoglobin in arterial blood, providing a continuous, real-time assessment of respiratory status. They are standard equipment in operating rooms, intensive care units, and emergency departments worldwide.

DQA devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Masimo Corporation, Nonin Medical, Inc. and Nellcor Puritan Bennett, Inc..