FDA 510(k) Application Details - K171578

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K171578
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen Aeon Technology Co.,Ltd. East 5/F, Block 15 Industrial Zone of majialong Nanshan District Shenzhen 51800 CN Other 510(k) Applications for this Company
Contact	Applicant Wendy 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	05/31/2017
Decision Date	11/30/2017
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