Masimo’s RD SET Sensors Receive 510(k) Clearance

October 26, 2018

The FDA granted 510(k) clearance for Masimo’s RD SET sensors.

The sensors measure a patient’s peripheral capillary oxygen saturation (SpO2) — estimating how much oxygen is in the blood. The sensors measure the percentage of oxygenated hemoglobin compared to the amount of hemoglobin contained in the blood.

With the FDA’s new clearance, the sensors will now feature improved SpO2 accuracy for patients that weigh under 6.5 pounds.

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