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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K121628
Device Name EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
Original Applicant
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD
1200 19th street, nw
washington,  DC  20032
Original Contact karl m nobert
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Codes
DPS   DSH  
Date Received06/04/2012
Decision Date 06/25/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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