510(k) K200876 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 4, 2020 |
| Received | Apr 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. DEXCOM G6 SENSOR 3 PACK
Item Number: 5447552 Open, Classified |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.