FDA 510(k) Application Details - K202296

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K202296
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Lijuan Du 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	08/13/2020
Decision Date	07/23/2021
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