MouthLab Vital Signs Monitoring System

MouthLab Vital Signs Monitoring System is an FDA 510(k)-cleared medical device (K201635) manufactured by Multisensor Diagnostics (Dba Aidar Health). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2021. Regulation: 8.