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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 K172121
Device Name Digital Thermometer
Applicant
Fudakang Industrial Co., Ltd.
# 8 Yinghe Rd., Yuanjiangyuan Management Zone,
Changping Town
Dongguan,  CN 523560
Applicant Contact Bob Yu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
# 55 Shizhou Middle Rd. , 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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