FDA 510(k) Application Details - K160358

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K160358
Device Name	Thermometer, Electronic, Clinical
Applicant	Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup Wonju-si 220-801 KR Other 510(k) Applications for this Company
Contact	Min-hye Kim 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	02/09/2016
Decision Date	02/24/2017
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