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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 K120672
Device Name KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
Applicant
ANDON HEALTH CO.,LTD
116 VILLAGE BOULEVARD
SUITE 200
princeton,  NJ  08540
Applicant Contact thomas becze
Correspondent
ANDON HEALTH CO.,LTD
116 VILLAGE BOULEVARD
SUITE 200
princeton,  NJ  08540
Correspondent Contact thomas becze
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/05/2012
Decision Date 06/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Clinical Trials NCT01575067
Reviewed by Third Party No
Combination Product No
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