510(k) K221259
- Device
- Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
- 510(k) number
- K221259
- Product code
- QBJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-29
- Date received
- 2022-05-02
- Regulation
- 862.1355
- Classification name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rachel Ellena
- Address
- 6340 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3013820501
- 3006537560
- 3027503105
- 2024024
- 3021611414
- 3008717264
- 3009888344
- 3037326582
- 3006371704
- 3007421145
- 3012448339
- 3016904853
- 3010220595
- 3004753838
- 3013435121
- 3011120183
- 2029015
- 2030598
- 3009901017
- 3004105270
- 3038285067
- 3002807314
- 3019807891
- 3003600763
- 3033394445
- 1450743
- 2954323
- 3012302888
- 9710492
- 3011536730
- 2032098
Source Documents#
Other 510(k) Records For Product Code QBJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2026-02-03 |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2025-12-17 |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | 2025-04-09 |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024-04-23 |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2024-04-23 |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024-02-26 |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023-05-15 |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2023-04-13 |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2023-03-03 |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023-01-11 |
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022-12-07 |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021-07-15 |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2020-12-04 |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | 2019-06-28 |
| K183206 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2019-02-14 |
Legacy Summary#
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FDA Review#
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