FDA 510(k) Application Details - K001305

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K001305
Device Name	Computer, Diagnostic, Programmable
Applicant	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 13000 EXECUTIVE DR. SUGARLAND, TX 77478 US Other 510(k) Applications for this Company
Contact	J. LAN MCDONALD 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	04/24/2000
Decision Date	06/27/2000
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