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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 K160145
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 Received01/21/2016
Decision Date 03/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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