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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 K162338
Device Name Full Automatic (NIBP) Blood Pressure Monitor
Applicant
HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
ZHONGHE DISTRICT, NEW TAIPEI CITY,  TW 23553
Applicant Contact SARAH SU
Correspondent
HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
ZHONGHE DISTRICT, NEW TAIPEI CITY,  TW 23553
Correspondent Contact SARAH SU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/22/2016
Decision Date 09/21/2016
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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