Regulation Number: 21 CFR 870.2700
Product Code: DQA,DPS

Compliance Consultants has worked on concept plans and claims Compliance Consultants has submitted 510(k) applications for pulse oximeter (oxymeter). These small devices have created an entire diagnostic facility to patients that were once available only in labs. They measure and display the oxygen saturation in the blood. These devices typically use a complex, proprietary red and infrared energy (660 nm and 880 nm) energy (plethysmograms) beamed onto the finger. A sensor assembly measures a complex array of reflected red and infrared energy. Blood reflections are calibrated to yield the absorption of oxygen. The calibration is computed by a computerized, sophisticated algorithm. The law of Lambert Beer is most common foundation for this algorithm. The results are displayed as oxygen saturation.