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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
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,  CN 300190
Applicant Contact LIU YI
Correspondent
ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN,  CN 300190
Correspondent Contact LIU YI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/17/2012
Decision Date 06/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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