Omnipod DASH Insulin Management System with interoperable technology

Omnipod DASH Insulin Management System with interoperable technology is an FDA 510(k)-cleared medical device (K191679) manufactured by Insulet Corporation. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 2019. Regulation: 8.