Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K121133 |
Device Name |
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU |
SEOUL,
KR
139-845
|
|
Applicant Contact |
HYUN JOON OH |
Correspondent |
i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU |
SEOUL,
KR
139-845
|
|
Correspondent Contact |
HYUN JOON OH |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/13/2012 |
Decision Date | 07/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|