FDA 510(k) Application Details - K021366

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K021366
Device Name	Computer, Diagnostic, Programmable
Applicant	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	LISA LEE MICHELS Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2002
Decision Date	07/03/2002
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