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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 K113485
Model ECG-1101G(I), ECG-1103LW(I), ECG-1103LW(I), ECG-1106L, ECG-1112, ECG-1112D
Device Name ELECTROCARDIOGRAPH
Original Applicant
SHENZHEN CAREWELL ELECTRONICS CO., LTD
p.o. box 237-023
shanghai,  CH 200030
Original Contact diana hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/23/2011
Decision Date 04/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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