510(k) K162602

NovoPen Echo by Novo Nordisk, Inc. — Product Code FMF

K162602 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NovoPen Echo". The FDA issued a decision of Substantially Equivalent on October 18, 2016. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Novo Nordisk, Inc. has at least 10 other 510(k) clearances on record.