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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number870.2340
Classification Product Code
DPS  
Date Received05/24/2011
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
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