SFI · Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
· Class 3
Overview
| Product Code | SFI |
|---|---|
| Device Name | Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250012 | Simplera Sync Sensor, Guardian 4 Sensor | Medtronic Minimed, Inc. | Aug 6, 2025 | APPR |
Top Applicants
- Medtronic Minimed, Inc. — 1 clearance
