FDA 510(k) Application Details - K210171

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K210171
Device Name	Thermometer, Electronic, Clinical
Applicant	Sichuan YOUKEDE Medical Equipment Co.,Ltd 2F, North Wing, No.102 Building, Mianyang Export Processing Zone, No.261 East Section of Feiyun Road, Mianyang Hi-Tech Mianyang 621000 CN Other 510(k) Applications for this Company
Contact	Sukey Chia 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	01/22/2021
Decision Date	03/18/2022
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