QII

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Product code

QII

Device name

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Device class

Class 2

21 CFR

21 CFR 862.1355

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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