FDA 510(k) Application Details - K221211

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K221211
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen Yolanda Technology Co., Ltd Room 201, Jinfulai Building, No.49-1, Dabao, Road, Dalang Area, Xinan Street, Baoan Shenzhen 518101 CN Other 510(k) Applications for this Company
Contact	Baihua Han 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	04/27/2022
Decision Date	09/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review