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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 K050587
Device Name FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
Applicant
Health & Life Co., Ltd.
9f, #186, Jian Yi Rd.
Chung Ho City, Taipei, Hsien,  TW 235
Applicant Contact PAUL HUNG
Correspondent
Health & Life Co., Ltd.
9f, #186, Jian Yi Rd.
Chung Ho City, Taipei, Hsien,  TW 235
Correspondent Contact PAUL HUNG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/08/2005
Decision Date 04/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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