Masimo Root Vital Signs Monitoring System and Accessories

Masimo Root Vital Signs Monitoring System and Accessories is an FDA 510(k)-cleared medical device (K151644) manufactured by Masimo Corporation. 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 11, 2016. Regulation: 8.