Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K140325 |
Device Name |
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System |
Applicant |
JOINSOON MEDICAL TECHNOLOGY CO, LTD. |
55 NORTHERN BLVD, SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
MARIA GRIFFIN |
Correspondent |
JOINSOON MEDICAL TECHNOLOGY CO, LTD. |
55 NORTHERN BLVD, SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
MARIA GRIFFIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/10/2014 |
Decision Date | 10/13/2015 |
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
|
|
|