Product code OZP

Device name

Automated Insulin Dosing Device System, Single Hormonal Control

Medical specialty

Unknown

Device class

3

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset