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First received: November 20, 2023

Clinical Trial: SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy

Study Type: INTERVENTIONAL


Official Title: Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion

Brief Summary: The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving.The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.

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