FDA 510(k) Application Details - K090147

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K090147
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 HIRRLINGEN 72145 DE Other 510(k) Applications for this Company
Contact	ANASTASIA MUELLER 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	01/21/2009
Decision Date	04/22/2009
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