FDA 510(k) Application Details - K092648

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K092648
Device Name	Ventilator, Continuous, Facility Use
Applicant	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1740 GOLDEN MILE HWY MONROEVILLE, PA 15146 US Other 510(k) Applications for this Company
Contact	ZITA A YURKO Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2009
Decision Date	12/18/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review