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DX Series Pulse Oximeter Sensors are multi-patient-use sensors intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry monitors or modules in multi-parameter systems are indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

The DX Series Pulse Oximeter Sensors combine the operational characteristics of pulse oximetry sensors that have already received Substantially Equivalent determination from FDA (K993979 and K010451) into new Finger Sensor and Y-Sensor configurations that, like the predicate devices, share the same outward physical designs and fundamental scientific technology. The modification enables a sensor to be used with Dixtal's existing pulse oximeter monitor devices as currently listed, as well as to function with other pulse oximetry products. The modified sensors allow healthcare practitioners to more widely standardize pulse oximetry sensors and applicator accessories, and to minimize potential Human Factors issues that might result from using sensors and applicator accessories from multiple manufacturers.