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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 K042265
Device Name FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
Applicant
HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
CHUNG HO CITY, TAIPEI,  TW 235
Applicant Contact PAUL HUNG
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 Received08/23/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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