ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA is an FDA 510(k)-cleared medical device (K060876) manufactured by Disetronic Medical Systems AG. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2006. Regulation: 8.