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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 K030499
Device Name HL888HM
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 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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