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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 K092163
Device Name FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
Applicant
Health & Life Co., Ltd.
9f, #186, Jian Yi Rd.
Chung Ho City, Taipei, Hsien,  TW 235
Applicant Contact SARAH SU
Correspondent
Center For Measurement Standards of Industrial
Bldg. 16, 321 Kuang Fu Rd.,Sec2
Hsinchu,,  TW
Correspondent Contact TZU-WEI LI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/16/2009
Decision Date 11/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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