The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Stellant Ct Injector System With Imaging System Interface Module.
Device ID | K033881 |
510k Number | K033881 |
Device Name: | MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE |
Classification | Injector And Syringe, Angiographic |
Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
Contact | Troy A Jack |
Correspondent | Troy A Jack MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-15 |
Decision Date | 2004-03-02 |
Summary: | summary |