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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 K172121
Device Name Digital Thermometer
Applicant
Fudakang Industrial Co., Ltd
No. 8 Yinghe Road, Yuanjiangyuan Management Zone,
Changping Town
Dongguan,  CN 523560
Applicant Contact Bob Yu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
NO. 55 Shizhou middle road , Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Field Fu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/13/2017
Decision Date 06/07/2018
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
Predetermined Change
Control Plan Authorized		 No
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