FDA 510(k) Application Details - K090539

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K090539
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 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	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2009
Decision Date	10/30/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review