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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 K120188
Models SE-12, SE-1200, SE-1200EXPRESS, SE-1201, SE-12EXPRESS
Device Name ELECTROCARDIOGRAPH
Original Applicant
EDAN INSTRUMENTS INC
3/f-b, nanshan medical
equipments park
shenzhen,  CH 518067
Original Contact yue qiuhong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/23/2012
Decision Date 03/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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