REKA E100


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

Correspodent Contact larry petersen
Regulation Number 870.2340
Classification Product Code
DPS  
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