FDA 510(k) Application Details - K223807

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K223807
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen SINO-K Medical Technology Co.,Ltd Room401,Bldg2, Veteran Ind.City,Gongle Community Xixiang Street,Baoan District Shenzhen 518115 CN Other 510(k) Applications for this Company
Contact	Lao Chengxin 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	12/20/2022
Decision Date	08/25/2023
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