Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa

• • Terminated Z-1646-2009 FDA Unclassified (pre-2012) ·initiated 30 Apr 2009

  The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.

510(k) Number

K060876 ↗

FDA Product Code

LZG

Models / Variants

Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001

Accu-Chek Insulin Pump Configuration Softwa

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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