510(k) K182387

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

K182387 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 December 17, 2018. 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.