FDA 510(k) Application Details - K984058

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K984058
Device Name	Injector, Contrast Medium, Automatic
Applicant	ACIST MEDICAL SYSTEMS 10250 VALLEY VIEW RD., #117 EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	KATE ANDERSON Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	IZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/1998
Decision Date	02/11/1999
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