FDA 510(k) Application Details - K130300

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K130300
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	HELDER A SOUSA Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2013
Decision Date	07/01/2013
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