Panels › Clinical Chemistry › Product code PHV · Class 1
Continuous Glucose Monitor Retrospective Data Analysis Software
Regulation 862.2120
0510(k)s in 12 months (1 all time)
2recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in PHV
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic MiniMed, Inc. | 0 | 2 |
| Dexcom, Inc. | 1 | 0 |
| Medtronic Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2026 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Nov 25, 2025 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Aug 5, 2016 | Medtronic Inc. CareLink iPro Version 1.10, Catalog No. MMT-7340
With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides repo Terminated |
PHV | None listed |
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