FDA 510(k) Application Details - K160802

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K160802
Device Name	Thermometer, Electronic, Clinical
Applicant	HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. 38 YANGJIATANG, SANDUN, WESTLAKE DISTRICT HANGZHOU CITY 310030 CN Other 510(k) Applications for this Company
Contact	JIAQIANG WAN 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	03/23/2016
Decision Date	08/24/2016
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