510(k) K191450 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 28, 2019 |
| Received | May 31, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191450
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2020 | Dexcom Inc Dexcom G6 Continuous Glucose Monitoring System
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in perso Terminated |
QBJ | None listed |
| Nov 19, 2019 | Dexcom Inc Brand Name: Dexcom G6 CGM App for iOS
Software Number: SW11677
Software Version: Version 1.4.0 up to corrected Version 1.4.4
GUDID Registered GTIN: 00386270000804 Terminated |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.