QDL

Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

Product code

QDL

Device name

Integrated Continuous Glucose Monitoring System For Professional Retrospective 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 retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use 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).