FDA 510(k) Application Details - K943803

Device Classification Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K943803
Device Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant	JANUS BIOMEDICAL, INC. 2525 HARTFORD RD. AUSTIN, TX 78703 US Other 510(k) Applications for this Company
Contact	RICHARD MARTIN Other 510(k) Applications for this Contact
Regulation Number	870.4220   More FDA Info for this Regulation Number
Classification Product Code	DTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1994
Decision Date	01/30/1996
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