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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 K163603
Device Name Digital Thermometer
Applicant
Guangzhou Jinxinbao Electronic Co., Ltd.
#38 Huanzhen Xi Rd., Dagang Town, Nansha Distric
Guangzhou,  CN 511470
Applicant Contact Mowu Zhu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, International Mayors Communication Centre
Shenzhen,  TW 518101
Correspondent Contact Elly Xu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/21/2016
Decision Date 06/06/2017
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
Predetermined Change
Control Plan Authorized		 No
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