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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 K093831
Device Name FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT
Applicant
Health & Life Co., Ltd.
9f, #186, Jian Yi Rd.
Chung Ho City, Taipei, Hsien,  TW 235
Applicant Contact SARAH SU
Correspondent
Health & Life Co., Ltd.
9f, #186, Jian Yi Rd.
Chung Ho City, Taipei, Hsien,  TW 235
Correspondent Contact SARAH SU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/14/2009
Decision Date 03/25/2010
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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