FDA 510(k) Application Details - K170723

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K170723
Device Name	Thermometer, Electronic, Clinical
Applicant	E-Care Technology Co., Ltd. 8F-11, No. 35, Hsintai Road Chubei 302 TW Other 510(k) Applications for this Company
Contact	K.Y. Ko 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	03/09/2017
Decision Date	10/25/2018
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