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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 K023834
Device Name HL888
Applicant
Health & Life Co., Ltd.
6f,#407, Chung Shan Rd.
Sec.02, Chung Ho City
Taipei Hsien,  TW 235
Applicant Contact SUSAN CHEN
Correspondent
Center For Measurement Standards of Industrial
Bldg. 16, 321 Kuang Fu Rd.,Sec2
Hsinchu,,  TW
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/18/2002
Decision Date 01/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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