FDA 510(k) Application Details - K243082

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K243082
Device Name	Thermometer, Electronic, Clinical
Applicant	Guangzhou Daxin Health Technology Co., Ltd Room 810, No.1, Yichuang Street, Huangpu District, Guangzhou (China-Singapore Guangzhou Knowledge City) Guangzhou 510700 CN Other 510(k) Applications for this Company
Contact	LuPeng Guo 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	09/30/2024
Decision Date	04/25/2025
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