Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K131230 |
Device Name |
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION |
Applicant |
PHILOSYS, INC. |
304 PARK AVENUE SOUTH |
SUITE 218 |
NEW YORK,
NY
10010
|
|
Applicant Contact |
LINDA CHAN |
Correspondent |
PHILOSYS, INC. |
304 PARK AVENUE SOUTH |
SUITE 218 |
NEW YORK,
NY
10010
|
|
Correspondent Contact |
LINDA CHAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/30/2013 |
Decision Date | 08/04/2014 |
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
|
|
|