FDA 510(k) Application Details - K113214

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K113214
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. ANN ARBOR, MI 48103 US Other 510(k) Applications for this Company
Contact	REBECCA ANDERSEN Other 510(k) Applications for this Contact
Regulation Number	870.2450   More FDA Info for this Regulation Number
Classification Product Code	DXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2011
Decision Date	02/07/2012
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