FDA 510(k) Application Details - K112645

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K112645
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	EIZO GMBH SIEMENSALLEE 84 D-76187 KARLSRUBE DE Other 510(k) Applications for this Company
Contact	BERND HOMBERG 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	09/12/2011
Decision Date	09/22/2011
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