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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 K160336
Device Name Full Automatic (NIBP) Blood Pressure Monitor
Applicant
Health & Life Co., Ltd.
9F, No. 186, Jian Yi Road
Zhonghe District, New Taipei City,  CN 23553
Applicant Contact Sarah Su
Correspondent
Health & Life Co., Ltd.
9F, No. 186, Jian Yi Road
Zhonghe District, New Taipei City,  CN 23553
Correspondent Contact Sarah Su
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/08/2016
Decision Date 03/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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