FDA 510(k) Application Details - K093124

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K093124
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	MONTHER ABUSHABAN 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	10/02/2009
Decision Date	03/10/2010
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