FDA 510(k) Application Details - K222588

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K222588
Device Name	Thermometer, Electronic, Clinical
Applicant	iWEECARE Co., Ltd. 1F., No. 11, Ln. 382, Zhonghe St., Beitou Dist., Taipei City 112, Taiwan Taipei City 112 TW Other 510(k) Applications for this Company
Contact	Julia 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	08/26/2022
Decision Date	02/17/2023
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