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First received: May 21, 2023

Clinical Trial: A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Oxygen Saturation

Study Type: INTERVENTIONAL


Official Title: A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers

Brief Summary: It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice.The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States.According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%.To prove compliance with this requirement, it is necessary…

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