510(k) K193642
- Device
- Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
- 510(k) number
- K193642
- Product code
- QDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-01-29
- Date received
- 2019-12-30
- Regulation
- 862.1355
- Classification name
- Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
- 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
- Linda Wang
- Address
- 6340 Sequence Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3012302888
- 2024024
- 3008717264
- 3004753838
- 3012448339
- 3013435121
- 2032098
- 3009901017
Source Documents#
Other 510(k) Records For Product Code QDK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021-08-17 |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | Dexcom, Inc. | 2019-10-25 |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018-10-26 |