iSage Rx (iSage Rx Basal Insulin Titration)

iSage Rx (iSage Rx Basal Insulin Titration) is an FDA 510(k)-cleared medical device (K161865) manufactured by Isag Rx, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 2017. Regulation: 8.