Product code OZQ

Device name

Automated Insulin Dosing Device System, Bihormonal 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

A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.

Source

FDA openFDA device classification dataset