Definition: Continuous Glucose Monitor Retrospective Data Analysis Software Is Intended To Analyze And Correlate Retrospective Data From A Continuous Glucose Monitoring Device.
| Device Type ID | 659 |
| Device Name | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Physical State | Software |
| Technical Method | Data Analysis System |
| Target Area | Not Applicable |
| 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 | 862.2120 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PHV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 659 |
| Device | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Product Code | PHV |
| FDA Device Classification | Class 1 Medical Device |
| CFR Regulation Number | 862.2120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEXCOM, INC. | ||
GRANTED | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc. | II | Sep-27-2016 |