FDA 510(k) Application Details - K201508

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K201508
Device Name	Thermometer, Electronic, Clinical
Applicant	Dongguan Prestige Sporting Goods Co., Ltd 3rd Industrial, Qiaotou Area, Houjie Town Dongguan 518118 CN Other 510(k) Applications for this Company
Contact	Zhang Zhao 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	06/05/2020
Decision Date	03/09/2021
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