Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K111456 |
Device Name |
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
RM 1301, GYEONGGI VENT. ANYANG |
SCI UNIV., 572-5 ANYANG 8-DONG |
MANAN-GU ANYANG-SI GYEONGGI-DO,
KR
430-731
|
|
Applicant Contact |
HL JUNG |
Correspondent |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
RM 1301, GYEONGGI VENT. ANYANG |
SCI UNIV., 572-5 ANYANG 8-DONG |
MANAN-GU ANYANG-SI GYEONGGI-DO,
KR
430-731
|
|
Correspondent Contact |
HL JUNG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/25/2011 |
Decision Date | 02/28/2012 |
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
|
|
|