| Device Type ID | 2848 |
| Device Name | Controller, Closed-loop Blood Glucose |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LHE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2848 |
| Device | Controller, Closed-loop Blood Glucose |
| Product Code | LHE |
| FDA Device Classification | Class 3 Medical Device |