Continuous Glucose Monitor Secondary Display

What Is This Device?

The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient’s continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring

How Is PJT Classified?

Continuous Glucose Monitor Secondary Display is FDA product code PJT, Class 2, 21 CFR 862.1350.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.