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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 K082734
Device Name A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
Applicant
A & D ENGINEERING, INC.
1756 AUTOMATION PARKWAY
SAN JOSE,  CA  95131
Applicant Contact JERRY WANG
Correspondent
A & D ENGINEERING, INC.
1756 AUTOMATION PARKWAY
SAN JOSE,  CA  95131
Correspondent Contact JERRY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/18/2008
Decision Date 11/13/2008
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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