FDA 510(k) Application Details - K240109

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K240109
Device Name	Thermometer, Electronic, Clinical
Applicant	Zhuzhou Goldenhot Medical Technology Co.,Ltd. Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District Zhuzhou 412000 CN Other 510(k) Applications for this Company
Contact	Xianwu Liu Other 510(k) Applications for this Contact
Regulation Number	880.2910   More FDA Info for this Regulation Number
Classification Product Code	FLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2024
Decision Date	04/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review