FDA 510(k) Application Details - K172121

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K172121
Device Name	Thermometer, Electronic, Clinical
Applicant	Fudakang Industrial Co., Ltd No. 8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town Dongguan 523560 CN Other 510(k) Applications for this Company
Contact	Bob Yu 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	07/13/2017
Decision Date	06/07/2018
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