FDA 510(k) Application Details - K161650

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K161650
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	Neurotronics, Inc. 3600 NW 43rd Street, STE F1 Gainesville, FL 32606 US Other 510(k) Applications for this Company
Contact	David Pezet Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2016
Decision Date	01/19/2017
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