FDA 510(k) Application Details - K133157

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K133157
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	MEDTRONIC, INC. 7611 NORTHLAND DRIVE MINNEAPOLIS, MN 55428 US Other 510(k) Applications for this Company
Contact	JESSICA SIXBERRY Other 510(k) Applications for this Contact
Regulation Number	870.4330   More FDA Info for this Regulation Number
Classification Product Code	DRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2013
Decision Date	10/23/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review