FDA 510(k) Application Details - K222057

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K222057
Device Name	Thermometer, Electronic, Clinical
Applicant	T&R BIOFAB CO., LTD. 542, Korea Polytechnic University, 237, Sangidaehak-ro Siheung-si 15073 KR Other 510(k) Applications for this Company
Contact	Woo-Soo Yun 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	07/12/2022
Decision Date	12/05/2023
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