510(k) K063146

ACCU-CHEK LINKASSIST by Disetronic Medical Systems AG — Product Code KZH

K063146 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "ACCU-CHEK LINKASSIST". The FDA issued a decision of Substantially Equivalent on November 27, 2006. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.