FDA 510(k) Application Details - K162627

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K162627
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	EnsoData, Inc. 111 N. Fairchild Street, Suite 240 Madison, WI 53703 US Other 510(k) Applications for this Company
Contact	Chris Fernandez Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2016
Decision Date	03/31/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review