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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 K160308
Device Name Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
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.
2032#, International Mayor Communication Center
Shizhou Zhong Rd. 55#, Na
Shenzhen,  CN 518100
Correspondent Contact Field Fu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/04/2016
Decision Date 07/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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