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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 K990807
Device Name HL148 & HL168
Applicant
Health & Life Co., Ltd.
4f-3, # 351, Chung Shan Rd.
Sec.02, Chung Ho City
Taipei Hsien,  TW
Applicant Contact SUSAN CHEN
Correspondent
Health & Life Co., Ltd.
4f-3, # 351, Chung Shan Rd.
Sec.02, Chung Ho City
Taipei Hsien,  TW
Correspondent Contact SUSAN CHEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/11/1999
Decision Date 12/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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