510(k) K113007

BIONIME DIABETES MANAGEMENT SYSTEM VI.0 by Bionime Corporation — Product Code JQP

K113007 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "BIONIME DIABETES MANAGEMENT SYSTEM VI.0". The FDA issued a decision of Substantially Equivalent on February 27, 2012. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Bionime Corporation has at least 10 other 510(k) clearances on record.