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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 K160019
Device Name U80 Series Upper Arm Electronic Blood Pressure Monitor
Applicant
Shenzhen Urion Technology Co., Ltd.
4th Bldg., Hi-Tech Industrial Zone,
Heping Community, Fuyong St., Baoan
Shenzhen,  CN 518103
Applicant Contact AUTUMN LIU
Correspondent
Shenzhen Urion Technology Co., Ltd.
4th Bldg., Hi-Tech Industrial Zone,
Heping Community, Fuyong St., Baoan
Shenzhen,  CN 518103
Correspondent Contact AUTUMN LIU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/05/2016
Decision Date 04/22/2016
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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