Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400

• • Terminated Z-0307-2018 FDA Class II ·initiated 22 Nov 2017

  Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.

• • Terminated Z-1235-2010 FDA Unclassified (pre-2012) ·initiated 23 Dec 2009

  The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.

510(k) Number

K982838 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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