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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 K141683
Device Name ELECTRONIC BLOOD PRESSURE MONITOR
Applicant
Shenzhen Urion Technology Co., Ltd.
4th Bldg., Hi-Tech Industrial Zone,
Heping Community, Fuyong St., Baoan District
Shenzhen,  CN 518103
Applicant Contact AUTUMN LIU
Correspondent
Shenzhen Urion Technology Co., Ltd.
4th Bldg., Hi-Tech Industrial Zone,
Heping Community, Fuyong St., Baoan District
Shenzhen,  CN 518103
Correspondent Contact AUTUMN LIU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/23/2014
Decision Date 04/03/2015
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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