RTMsense Respiratory Monitoring System

RTMsense Respiratory Monitoring System is an FDA 510(k)-cleared medical device (K243183) manufactured by Rtm Vital Signs, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 26, 2025. Regulation: 8.