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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 K160014
Device Name iHealth Track 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 Received01/04/2016
Decision Date 02/02/2016
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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