Omnipod Insulin Management System, Omnipod DASH Insulin Management System

Omnipod Insulin Management System, Omnipod DASH Insulin Management System is an FDA 510(k)-cleared medical device (K182630) manufactured by Insulet Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 2019. Regulation: 8.