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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 K083247
Device Name FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
Applicant
Andon Health Co, Ltd.
No 31, Changjiang Rd.
Nankai District
Tianjin,  CN 300190
Applicant Contact LIU YI
Correspondent
Andon Health Co, Ltd.
No 31, Changjiang Rd.
Nankai District
Tianjin,  CN 300190
Correspondent Contact LIU YI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/03/2008
Decision Date 01/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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