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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 K121470
Model KD-972
Device Name FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
Applicant
ANDON HEALTH CO., LTD
no. 3 jin ping street,ya an road,
nankai district
tianjin, 
Contact liu yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/17/2012
Decision Date 06/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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