510(k) K243183

RTMsense Respiratory Monitoring System by Rtm Vital Signs, LLC — Product Code BZQ

K243183 is an FDA 510(k) premarket notification submitted by Rtm Vital Signs, LLC for the device "RTMsense Respiratory Monitoring System". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375.