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Continuous Glucose Monitor Informed Insulin Dose Calculator

Product code

QRX

Device name

Continuous Glucose Monitor Informed Insulin Dose Calculator

Device class

Class 2

21 CFR

21 CFR 862.1358

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-11-18.

2 summaries are archived here for direct download.