Device Classification Name |
integrated continuous glucose monitoring system, factory calibrated
|
510(k) Number |
K234133 |
Device Name |
Dexcom G7 Continuous Glucose Monitoring System |
Applicant |
Dexcom Inc. |
6340 Sequence Dr |
San Diego,
CA
92121
|
|
Applicant Contact |
Neeta Sharma |
Correspondent |
Dexcom Inc. |
6340 Sequence Dr |
San Diego,
CA
92121
|
|
Correspondent Contact |
Michelle Monroe |
Regulation Number | 862.1355
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/2023 |
Decision Date | 02/26/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04794478
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|