The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Acist Injector System, Model Cl100 H.
| Device ID | K984058 |
| 510k Number | K984058 |
| Device Name: | ACIST INJECTOR SYSTEM, MODEL CL100 H |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | ACIST MEDICAL SYSTEMS 10250 VALLEY VIEW RD., #117 Eden Prairie, MN 55344 |
| Contact | Kate Anderson |
| Correspondent | Kate Anderson ACIST MEDICAL SYSTEMS 10250 VALLEY VIEW RD., #117 Eden Prairie, MN 55344 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1999-02-11 |
| Summary: | summary |