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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 K170662
Device Name Non Contact Infrared Forehead Thermometer
Applicant
Intrinity Global Limited
Room 1707, 17/F, Westley Square
48Hoi Yuen Road, Kwun Tong
Hong Kong,  CN 999077
Applicant Contact Alex Kwok
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
NO. 55 Shizhou middle road, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Elly Xu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/03/2017
Decision Date 11/22/2017
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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