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