The following data is part of a premarket notification filed by Nycomed Amersham Imaging with the FDA for Premica Ct Contrast Media Delivery System.
| Device ID | K983314 |
| 510k Number | K983314 |
| Device Name: | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | NYCOMED AMERSHAM IMAGING 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson NYCOMED AMERSHAM IMAGING 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1999-02-19 |
| Summary: | summary |