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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K110775
Device Name ELECTRONIC SPHYGMOMANOMETER
Applicant
CONTEC MEDICAL SYSTEMS CO., LTD.
P.O. BOX 237-423
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
CONTEC MEDICAL SYSTEMS CO., LTD.
P.O. BOX 237-423
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/21/2011
Decision Date 05/13/2011
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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