FDA 510(k) Application Details - K021495

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K021495
Device Name	Computer, Diagnostic, Programmable
Applicant	PIE MEDICAL IMAGING B.V. 7992 CASTLEWAY DR. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	COLLEEN DENSMORE 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	05/09/2002
Decision Date	10/01/2002
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