FDA 510(k) Application Details - K050994

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K050994
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	Cardinal Health 1430 WAUKEGAN RD. BUILDING KB MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	SHARON NICHOLS Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2005
Decision Date	08/03/2005
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