510(k) K062265

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM by Swiss Medical Care S.A. — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2006
Date Received
August 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type