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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 K030561
Device Name MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
Applicant
Mytech Technology Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Applicant Contact SHU CHEN CHENG
Correspondent
Mytech Technology Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Correspondent Contact SHU CHEN CHENG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/21/2003
Decision Date 05/09/2003
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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