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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
Device Name ELECTROCARDIOGRAPH
Applicant
SHENZHEN CAREWELL ELECTRONICS CO., LTD
P.O. BOX 237-023
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
SHENZHEN CAREWELL ELECTRONICS CO., LTD
P.O. BOX 237-023
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/23/2011
Decision Date 04/25/2012
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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