FDA 510(k) Application Details - K163601

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K163601
Device Name	Thermometer, Electronic, Clinical
Applicant	RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, HSIN CHU 30075 TW Other 510(k) Applications for this Company
Contact	Monica Chung 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	12/21/2016
Decision Date	12/06/2018
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