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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 K012472
Device Name A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
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 Received08/02/2001
Decision Date 02/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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