OZP

Automated Insulin Dosing Device System, Single Hormonal Control

Product code

OZP

Device name

Automated Insulin Dosing Device System, Single Hormonal Control

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.

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