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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 K170196
Device Name A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
Applicant
A&D Company, Ltd.
1756 Automation Parkway
san jose,  CA  95131
Applicant Contact jerry wang
Correspondent
A&D Company, Ltd.
1756 Automation Parkway
san jose,  CA  95131
Correspondent Contact jerry wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/23/2017
Decision Date 05/17/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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