FDA 510(k) Applications Submitted by Dexcom, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN140016 |
04/22/2014 |
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE |
DEXCOM, INC. |
| DEN140038 |
12/15/2014 |
Dexcom Share Direct Secondary Displays |
DEXCOM, INC. |
| K231081 |
04/17/2023 |
Dexcom G7 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
| K223931 |
12/30/2022 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
| K192787 |
09/30/2019 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System |
Dexcom, Inc. |
| K203089 |
10/13/2020 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
| K183206 |
11/19/2018 |
Dexcom G6 Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K191450 |
05/31/2019 |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K191833 |
07/09/2019 |
Dexcom G6 Pro Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K193642 |
12/30/2019 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
| K182041 |
07/30/2018 |
Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K200876 |
04/01/2020 |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K201328 |
05/19/2020 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
| DEN170088 |
12/08/2017 |
Dexcom G6 Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K213919 |
12/15/2021 |
Dexcom G7 Continuous Glucose Monitoring System |
Dexcom, Inc. |
| K221259 |
05/02/2022 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
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