FDA 510(k) Application Details - K110957

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K110957
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	SPECTRUM MEDICAL, LLP CHELTENHAM ROAD EAST GLOUCESTER GL2 9QL GB Other 510(k) Applications for this Company
Contact	STEVE TURNER 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	04/05/2011
Decision Date	05/31/2011
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	Y
Expedited Review