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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. #186, Jian Yi Rd.
Zhonghe District, New Taipei City,  TW 23553
Applicant Contact JS Hsu
Correspondent
Health & Life Co., Ltd.
9f. #186, Jian Yi Rd.
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
Predetermined Change
Control Plan Authorized		 No
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