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First received: May 23, 2025

Clinical Trial: Pulse Oximeter Validation Study for the Perin Health Patch

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Hypoxia

Study Type: OBSERVATIONAL


Official Title: Pulse Oximeter Validation Study for the Perin Health Patch

Brief Summary: The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia.This study will help determine whether the device meets the performance requirements of ISO 80601-2-61 and FDA 510(k) for SpO? measurement accuracy.The main questions it aims to answer is whether the Perin Health Patch meet the required accuracy performance (Arms ? 3.5%) across the…

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