510(k) K150874

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) by Novo Nordisk, Inc. — Product Code FMF

K150874 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)". The FDA issued a decision of Substantially Equivalent on Jul 31, 2015. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Novo Nordisk, Inc. has 14 other 510(k) clearances on record.