SmartLinx Vitals Plus Patient Monitoring System

SmartLinx Vitals Plus Patient Monitoring System is an FDA 510(k)-cleared medical device (K180734) manufactured by Capsule Technologie. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2018. Regulation: 8.