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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 K173191
Device Name A&D Medical Blood Pressure Monitors
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 Received10/02/2017
Decision Date 03/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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