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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 K152003
Device Name iHealth BP3L Wireless Blood Pressure Monitor
Applicant
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET, YA AN ROAD
NANKAI DISTRICT
TIANJIN,  CN 300190
Applicant Contact Liu Yi
Correspondent
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET, YA AN ROAD
NANKAI DISTRICT
TIANJIN,  CN 300190
Correspondent Contact Liu Yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/20/2015
Decision Date 09/24/2015
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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