FDA 510(k) Application Details - K192469

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K192469
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	Nox Medical Katrinartuni 2 Reykjavik 105 IS Other 510(k) Applications for this Company
Contact	Kolburn E Ottosdottir 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	09/09/2019
Decision Date	11/13/2019
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