VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM is an FDA 510(k)-cleared medical device (K132604) manufactured by Covidien. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2013. Regulation: 8.