510(k) K982966

DISETRONIC PEN by Disetronic Medical Systems — Product Code FMF

K982966 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DISETRONIC PEN". The FDA issued a decision of Substantially Equivalent on October 19, 1998. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Disetronic Medical Systems has at least 10 other 510(k) clearances on record.