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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 K914273
Device Name A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
Applicant
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Applicant Contact ALBERT J PINZA
Correspondent
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Correspondent Contact ALBERT J PINZA
Regulation Number870.1110
Classification Product Code
DSK  
Date Received09/24/1991
Decision Date 02/09/1993
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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