Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K082521 |
Device Name |
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
PO BOX 527 |
REHOVOT,
IL
76100
|
|
Applicant Contact |
ALEX GONOROVSKY |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
PO BOX 527 |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
ALEX GONOROVSKY |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/02/2008 |
Decision Date | 01/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|