Vios Monitoring System™ Model 2050

Vios Monitoring System™ Model 2050 is an FDA 510(k)-cleared medical device (K172586) manufactured by Vios Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2018. Regulation: 8.