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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K200802
Device Name Infrared Thermometer
Applicant
Shenzhen Urion Technology Co., Ltd.
4-6f Of Bldg. D, Jiale Science& Technology Industrial
Zone, Heshuikou Comm
Shenzhen,  CN 518106
Applicant Contact Autumn Liu
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community
Songgang St.
Shenzhen,  CN 518105
Correspondent Contact Changming Zhu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/27/2020
Decision Date 10/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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