FDA 510(k) Application Details - K042628

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K042628
Device Name	Computer, Diagnostic, Programmable
Applicant	RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 UPPSALA S-754 50 SE Other 510(k) Applications for this Company
Contact	HELENE EKSTRAND 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	09/27/2004
Decision Date	01/19/2005
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