SFI — Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Class III
FDA product code SFI covers "Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SFI
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.