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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K880079
Device Name TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
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 Number870.1110
Classification Product Code
DSK  
Date Received01/11/1988
Decision Date 03/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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