Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K200277 |
Device Name |
Livongo Blood Glucose Monitoring System (BG1000) |
Applicant |
Livongo Health, Inc. |
150 W. Evelyn Ave, Suite 150 |
Mountain View,
CA
94041
|
|
Applicant Contact |
Jacob Gendler |
Correspondent |
Livongo Health, Inc. |
150 W. Evelyn Ave, Suite 150 |
Mountain View,
CA
94041
|
|
Correspondent Contact |
Jacob Gendler |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 02/04/2020 |
Decision Date | 06/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|