NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) is an FDA 510(k)-cleared medical device (K182387) manufactured by Novo Nordisk, Inc.. 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 December 16, 2018. Regulation: 8.