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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 K102939
Device Name FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
Applicant
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET YA AN RD
NANKAI DISTRICT
tianjin,  CN 300190
Applicant Contact liu yi
Correspondent
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET YA AN RD
NANKAI DISTRICT
tianjin,  CN 300190
Correspondent Contact liu yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/04/2010
Decision Date 02/23/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Clinical Trials NCT01206959
Reviewed by Third Party No
Combination Product No
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