Definition: The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing
| Device Type ID | 664 |
| Device Name | Continuous Glucose Monitor Secondary Display |
| Physical State | Typically A Software Device Installed On A Third-party Mobile Device. |
| Technical Method | Receives And Displays Real-time Patient Data From A Continuous Glucose Monitor. |
| Target Area | N/a |
| Regulation Description | Continuous Glucose Monitor Secondary Display. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 664 |
| Device | Continuous Glucose Monitor Secondary Display |
| Product Code | PJT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Glucose Monitor Secondary Display. |
| CFR Regulation Number | 862.1350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEXCOM, INC. | ||
GRANTED | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Imprecision | 1 |
| Total Device Problems | 1 |