FDA 510(k) Application Details - K083340

Device Classification Name	Control, Pump Speed, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K083340
Device Name	Control, Pump Speed, Cardiopulmonary Bypass
Applicant	LEVITRONIX LLC. 45 FIRST AVE. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	SUSAN HAMANN Other 510(k) Applications for this Contact
Regulation Number	870.4380   More FDA Info for this Regulation Number
Classification Product Code	DWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2008
Decision Date	11/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review