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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 K083043
Device Name KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
Applicant
Shenzhen Kingyield Technology Co., Ltd.
Fuhai Rd.
Fuyong Town, Baoan District
Shenzhen, Guangdong,  CN 518103
Applicant Contact DACHENG GONG
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/14/2008
Decision Date 10/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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