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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 K093739
Device Name BLOOD PRESSURE MONITOR/ MODELS
Applicant
Ningbo Diaier Electronic Co., Ltd.
Yaoxi Industrial Zone
Yuyao City, Zhejiang,  CN
Applicant Contact LAO XIKUN
Correspondent
Ningbo Diaier Electronic Co., Ltd.
Yaoxi Industrial Zone
Yuyao City, Zhejiang,  CN
Correspondent Contact LAO XIKUN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/04/2009
Decision Date 05/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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