Resources & Downloads

Summary Report: US FDA 510(k) for Heart Rate

FaceHeart Vitals™ received US FDA 510(k) clearance (K223622) for contactless Heart Rate measurement in 2023. The summary report outlines the device description, intended use, performance testing, clinical validation methodology, etc.

Summary Report: FDA 510(k) for Respiratory Rate

FaceHeart Vitals™ received US FDA 510(k) clearance (K243966) for contactless Respiratory Rate measurement in 2025. The summary report outlines the device description, intended use, performance testing, clinical validation methodology, etc.