FDA 510(k) Application Details - K213485

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K213485
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District Shenzhen 518126 CN Other 510(k) Applications for this Company
Contact	Queena Chen 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	10/29/2021
Decision Date	05/25/2022
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