FDA 510(k) Application Details - K152301

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K152301
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 2568 Bristol Circle Oakville L6H5S1 CA Other 510(k) Applications for this Company
Contact	Sanjay Mehta Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2015
Decision Date	06/03/2016
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