PKU

Insulin Pump Secondary Display

Product code

PKU

Device name

Insulin Pump Secondary Display

Device class

Class 2

21 CFR

21 CFR 862.1350

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification definition

The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.

Definition text from the FDA device classification database (U.S. federal government work, public domain).