FDA 510(k) Application Details - K162012

Device Classification Name	Display, Cathode-Ray Tube, Medical   More FDA Info for this Device
510(K) Number	K162012
Device Name	Display, Cathode-Ray Tube, Medical
Applicant	GE HEALTHCARE 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	ROBERT CASARSA 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	07/21/2016
Decision Date	09/15/2016
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