Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K141862 |
Device Name |
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE |
Applicant |
H2 Inc. |
29222 RANCHO VIEJO RD, STE 218 |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
Feng-Yu Lee |
Correspondent |
H2 Inc. |
29222 RANCHO VIEJO RD, STE 218 |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Correspondent Contact |
Feng-Yu Lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/10/2014 |
Decision Date | 12/02/2014 |
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
|
|
|