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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 K163683
Device Name A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
Applicant
A&D Company, Ltd.
1756 Automation Pkwy.
San Jose,  CA  95131
Applicant Contact JERRY WANG
Correspondent
A&D Company, Ltd.
1756 Automation Pkwy.
San Jose,  CA  95131
Correspondent Contact JERRY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/28/2016
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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