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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K180314
Device Name Infrared Thermometer
Applicant
Xuzhou Yongkang Electronic Science Technology Co., Ltd
4F Building C8,40 Jingshan Road
Econonic and Technolgical Development Zone
Xuzhou,  CN 102628
Applicant Contact Xuecheng Zhao
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/05/2018
Decision Date 07/11/2018
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
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