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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 K092811
Device Name FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903
Applicant
Andon Health Co, Ltd.
No 31, Changjiang Rd.
Nankai District
Tianjin,  CN 300193
Applicant Contact LIU YI
Correspondent
Andon Health Co, Ltd.
No 31, Changjiang Rd.
Nankai District
Tianjin,  CN 300193
Correspondent Contact LIU YI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/14/2009
Decision Date 01/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT00952965
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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