FDA 510(k) Application Details - K062468

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K062468
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	SPECTRUM MEDICAL, LLP 27 BATH ROAD CHELTENHAM GL53 7TH 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	08/24/2006
Decision Date	09/13/2006
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