SmartLinx Vitals Plus Patient Monitoring System

SmartLinx Vitals Plus Patient Monitoring System is an FDA 510(k)-cleared medical device (K200856) manufactured by Capsule Technologie Sas. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2020. Regulation: 8.