FDA 510(k) Application Details - K223522

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K223522
Device Name	Thermometer, Electronic, Clinical
Applicant	Xiamen Intretech Inc. No.100, Dongfu West Road, Haicang District. Xiamen 361000 CN Other 510(k) Applications for this Company
Contact	Sunny Sun 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	11/23/2022
Decision Date	06/20/2023
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