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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 K171062
Device Name BP5S Wireless Blood Pressure Monitor
Applicant
Andon Health Co., Ltd.
No.3 Jin Ping Street
Ya An Road, Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co., Ltd.
No.3 Jin Ping Street
Ya An Road, Nankai District
Tianjin,  CN 300190
Correspondent Contact Liu Yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/10/2017
Decision Date 08/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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