FDA 510(k) Application Details - K202603

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K202603
Device Name	Thermometer, Electronic, Clinical
Applicant	iWEECARE Co., Ltd. 2F, No. 121, Sec. 2, Linong St., Beitou Dist., Taipei City 112 TW Other 510(k) Applications for this Company
Contact	Glen Tseng 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	09/08/2020
Decision Date	07/22/2021
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