FDA 510(k) Application Details - K050597

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K050597
Device Name	Ventilator, Continuous, Facility Use
Applicant	DATEX-OHMEDA, INC. PO BOX 7550 MADISON, WI 53707 US Other 510(k) Applications for this Company
Contact	DAN KOSEDNAR 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	03/09/2005
Decision Date	03/25/2005
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