K192872 is an FDA 510(k) clearance for the ulrichINJECT CT Motion. This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).
Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on July 2, 2020, 268 days after receiving the submission on October 8, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K192872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2019 |
| Decision Date | July 02, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | IZQ — Injector, Contrast Medium, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |