OZO

Automated Insulin Dosing , Threshold Suspend

Product code: OZO
Device name: Automated Insulin Dosing , Threshold Suspend
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

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

Official FDA classification page: OZO

Classification and pathway per current FDA publications. Data from openFDA (CC0).