FDA 510(k) Application Details - K201843

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K201843
Device Name	Thermometer, Electronic, Clinical
Applicant	Wenzhou Yosun Medical Technology Co., Ltd. No. 17, Shahong Road, Lingmen, Beibaixiang Town, Yueqing Wenzhou 325603 CN Other 510(k) Applications for this Company
Contact	Lihao Yang 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	07/06/2020
Decision Date	10/23/2020
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