FDA 510(k) Application Details - K052489

Device Classification Name	Conditioner, Signal, Physiological   More FDA Info for this Device
510(K) Number	K052489
Device Name	Conditioner, Signal, Physiological
Applicant	RESPIRONICS, INC. 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US Other 510(k) Applications for this Company
Contact	ZITA A YURKO Other 510(k) Applications for this Contact
Regulation Number	882.1845   More FDA Info for this Regulation Number
Classification Product Code	GWK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2005
Decision Date	09/27/2005
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	Y
Expedited Review