The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Acist Gentoo Contrast Injection System.
| Device ID | K020892 |
| 510k Number | K020892 |
| Device Name: | ACIST GENTOO CONTRAST INJECTION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie, MN 55344 |
| Contact | Carl M Beaurline |
| Correspondent | Carl M Beaurline ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 Eden Prairie, MN 55344 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-19 |
| Decision Date | 2003-01-27 |
| Summary: | summary |