Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K162203 |
Device Name |
POGO Automatic Blood Glucose Monitoring System |
Applicant |
Intuity Medical, Inc. |
526 Almanor Avenue |
Sunnyvale,
CA
94085
|
|
Applicant Contact |
Robb Hesley |
Correspondent |
Domecus Consulting Services LLC |
1171 Barroilhet Drive |
Hillsborough,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/05/2016 |
Decision Date | 04/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02333864
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|