FDA 510(k) Application Details - K182227

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K182227
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	Neurozone MSH Incorporated 17 Lantern Lane Dundas L9H 6N9 CA Other 510(k) Applications for this Company
Contact	Daniel Ramirez Rodriguez 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	08/16/2018
Decision Date	01/17/2019
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