PJT

Continuous Glucose Monitor Secondary Display

Product code

PJT

Device name

Continuous Glucose Monitor Secondary Display

Device class

Class 2

21 CFR

21 CFR 862.1350

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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

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