FDA 510(k) Application Details - K121849

Device Classification Name	Apparatus, Suction, Patient Care   More FDA Info for this Device
510(K) Number	K121849
Device Name	Apparatus, Suction, Patient Care
Applicant	CAREFUSION 1500 WAUKEGAN ROAD MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	JOY GREIDANUS Other 510(k) Applications for this Contact
Regulation Number	870.5050   More FDA Info for this Regulation Number
Classification Product Code	DWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2012
Decision Date	10/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review