Product code QRX

Device name

Continuous Glucose Monitor Informed Insulin Dose Calculator

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1358

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset