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 (K211575) 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 August 12, 2021. Regulation: 8.