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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 K240109
Device Name Medical electronic thermometer (FC01, FC02)
Applicant
Zhuzhou Goldenhot Medical Technology Co., Ltd.
Rm. 301, Plant C-3, Phase 5, Xinma Power Innovation Park,
# 889, Xianyue Huan Rd., Majiahe St.,Tianyuan District
Zhuzhou,  CN 412000
Applicant Contact Xianwu Liu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518000
Correspondent Contact Meihua Cai
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/16/2024
Decision Date 04/12/2024
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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