FDA 510(k) Application Details - K162509

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K162509
Device Name	Thermometer, Electronic, Clinical
Applicant	EASYWELL BIOMEDICALS, INC. SUITE 2, 2F, NO.9, JHANYE 1ST RD, HSINCHU SCIENCE PARK , Hsinchu 30078 TW Other 510(k) Applications for this Company
Contact	Arthur 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	09/08/2016
Decision Date	03/10/2017
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