510(k) K231081 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G7 Continuous Glucose Monitoring (CGM) System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 15, 2023 |
| Received | Apr 17, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2025 | Dexcom, Inc. Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system Open, Classified |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.