Resources & Downloads

Summary Report: FDA 510(k) for Heart Rate

FaceHeart Vitals™ received FDA 510(k) clearance (K223622) for contactless Heart Rate in 2023 — covering device description, intended use, performance testing, and clinical validation methodology.

Summary Report: FDA 510(k) for Respiratory Rate

FaceHeart Vitals™ received FDA 510(k) clearance (K243966) for contactless Respiratory Rate in 2025 — covering device description, intended use, performance testing, and clinical validation methodology.