510(k) K123766

NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN by Novo Nordisk, Inc. — Product Code FMF

K123766 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN". The FDA issued a decision of Substantially Equivalent on August 15, 2013. 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.