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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 K190133
Device Name Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
Applicant
Health & Life Co., Ltd.
9F. No.186, Jian Yi Road
Zhonghe District, New Taipei City,  TW 23553
Applicant Contact JS Hsu
Correspondent
Health & Life Co., Ltd.
9F. No.186, Jian Yi Road
Zhonghe District, New Taipei City,  TW 23553
Correspondent Contact JS Hsu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/28/2019
Decision Date 06/13/2019
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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