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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 K040371
Device Name A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
Applicant
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Applicant Contact JERRY WANG
Correspondent
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Correspondent Contact JERRY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/17/2004
Decision Date 05/19/2004
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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