OZQ — Automated Insulin Dosing Device System, Bihormonal Control Class III
FDA product code OZQ covers "Automated Insulin Dosing Device System, Bihormonal Control", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OZQ
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
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.