FDA 510(k) Application Details - K161728

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K161728
Device Name	Thermometer, Electronic, Clinical
Applicant	MICROFILE INTELLECTUAL PROPERTY GMBH ESPENSTRASSE 139 WIDNAU 9443 CH Other 510(k) Applications for this Company
Contact	GERHARD FRICK 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	06/22/2016
Decision Date	12/05/2016
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