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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 K160816
Device Name Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
Applicant
Nexmed Technology Co., Ltd.
2 Floor Of #1 Bldg.,
Jia An Technological Industrial Park, 67 District
Shenzhen,  CN 518000
Applicant Contact Ellen Xu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, International Mayors Communication Centre
Shenzhen,  CN 518101
Correspondent Contact Elena Lu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/24/2016
Decision Date 09/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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