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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 K161735
Device Name Non-contact Forehead Thermometer
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/23/2016
Decision Date 11/17/2016
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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