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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 K141946
Device Name DIGITAL ELECTROCARDIOGRAPH
Applicant
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 120-119
SHANGHAI,  CN 200120
Applicant Contact Diana Hong
Correspondent
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/17/2014
Decision Date 02/13/2015
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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