FDA 510(k) Application Details - K232473

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K232473
Device Name	Thermometer, Electronic, Clinical
Applicant	Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road Tangjiawan Town, High-tech Zone Zhuhai 519000 CN Other 510(k) Applications for this Company
Contact	Feng Yan 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	08/16/2023
Decision Date	02/09/2024
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