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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 K030498
Device Name HL888HA
Applicant
HEALTH & LIFE CO., LTD.
6F,NO.407, CHUNG SHAN RD.
SEC.02, CHUNG HO CITY
TAIPEI HSIEN,  TW 235
Applicant Contact SUSAN CHEN
Correspondent
HEALTH & LIFE CO., LTD.
6F,NO.407, CHUNG SHAN RD.
SEC.02, CHUNG HO CITY
TAIPEI HSIEN,  TW 235
Correspondent Contact SUSAN CHEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/19/2003
Decision Date 04/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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