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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 K080789
Device Name BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
Applicant
Sejoy Electronics & Instruments Co., Ltd.
6367 Bancroft Way
San Jose,  CA  95129
Applicant Contact JIANYAO WU
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/20/2008
Decision Date 04/03/2008
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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