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