510(k) K043000

MODIFICATION TO D-TRONPLUS by Disetronic Medical Systems AG — Product Code LZG

K043000 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "MODIFICATION TO D-TRONPLUS". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.