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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 K882824
Device Name TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
Applicant
A & D ENGINEERING, INC.
P.O. BOX 32427
SAN JOSE,  CA  95152
Applicant Contact KIMIO SHIBATA
Correspondent
A & D ENGINEERING, INC.
P.O. BOX 32427
SAN JOSE,  CA  95152
Correspondent Contact KIMIO SHIBATA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/08/1988
Decision Date 01/17/1989
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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