FDA 510(k) Application Details - K003499

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K003499
Device Name	Device, Sleep Assessment
Applicant	RESPIRONICS, INC. 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US Other 510(k) Applications for this Company
Contact	DAVID J VANELLA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2000
Decision Date	02/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review