Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K081703 |
Device Name |
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS |
Applicant |
ENTRA HEALTH SYSTEMS, LTD. |
7833 KNOLLBROOK DRIVE |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
CARLOS GONZALEZ |
Correspondent |
ENTRA HEALTH SYSTEMS, LTD. |
7833 KNOLLBROOK DRIVE |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
CARLOS GONZALEZ |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/17/2008 |
Decision Date | 01/08/2009 |
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
|
|
|