FDA 510(k) Application Details - K202142

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K202142
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 US Other 510(k) Applications for this Company
Contact	Jonquil Mau 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	07/31/2020
Decision Date	10/29/2020
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