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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 K895428
Device Name A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20
Applicant
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact KIMIO SHIBATA
Correspondent
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact KIMIO SHIBATA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/05/1989
Decision Date 11/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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