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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 K022926
Device Name GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
Applicant
Genteel Technology Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Genteel Technology Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/04/2002
Decision Date 06/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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