FDA 510(k) Application Details - K182133

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K182133
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen AOJ Medical Technology Co., Ltd. Room 202, HaoGu Industry Park, 2037 Guanguang road, Guangming district Shenzhen 518103 CN Other 510(k) Applications for this Company
Contact	Qihuan Zhao 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	08/06/2018
Decision Date	11/20/2018
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