The following data is part of a premarket notification filed by Swiss Medical Care S.a. with the FDA for Ct Expres Iii Contrast Media Delivery System.
| Device ID | K062265 |
| 510k Number | K062265 |
| Device Name: | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | SWISS MEDICAL CARE S.A. 32 STRATTON COURT Flemington, NJ 08822 |
| Contact | Robert Aromando |
| Correspondent | Robert Aromando SWISS MEDICAL CARE S.A. 32 STRATTON COURT Flemington, NJ 08822 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-04 |
| Decision Date | 2006-12-26 |
| Summary: | summary |