Device Classification Name |
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
|
510(k) Number |
K193642 |
Device Name |
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
Applicant |
Dexcom, Inc. |
6340 Sequence Drive |
San Diego,
CA
92121
|
|
Applicant Contact |
Linda Wang |
Correspondent |
Dexcom, Inc. |
6340 Sequence Drive |
San Diego,
CA
92121
|
|
Correspondent Contact |
Linda Wang |
Regulation Number | 862.1355
|
Classification Product Code |
|
Date Received | 12/30/2019 |
Decision Date | 01/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|