Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K123935 |
FOIA Releasable 510(k) |
K123935
|
Device Name |
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM |
Applicant |
ANDON MEDICAL CO., LTD. |
NO.26 HANGYU RD. |
TIANJIN AIRPORT ECONOMIC AREA |
TIANJIN,
CN
300381
|
|
Applicant Contact |
YI LIU |
Correspondent |
ANDON MEDICAL CO., LTD. |
NO.26 HANGYU RD. |
TIANJIN AIRPORT ECONOMIC AREA |
TIANJIN,
CN
300381
|
|
Correspondent Contact |
YI LIU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2012 |
Decision Date | 04/12/2013 |
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
|
|
|