Device Classification Name |
electrocardiograph
|
510(k) Number |
K111438 |
Device Name |
REKA E100 |
Applicant |
REKA PTE LTD |
1001 BEAR ISLAND ROAD |
SUITE 136 |
summerville,
SC
29483
|
|
Applicant Contact |
larry petersen |
Correspondent |
REKA PTE LTD |
1001 BEAR ISLAND ROAD |
SUITE 136 |
summerville,
SC
29483
|
|
Correspondent Contact |
larry petersen |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 05/24/2011 |
Decision Date | 09/12/2011 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|