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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 K061456
Device Name A & D MEDICAL UM-101 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 Received05/25/2006
Decision Date 06/21/2006
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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