The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Ulrichinject Ct Motion.
| Device ID | K210541 |
| 510k Number | K210541 |
| Device Name: | UlrichINJECT CT Motion |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm, DE 89081 |
| Contact | Sven Erdmann |
| Correspondent | Rita King MethodSense Inc. 1 Copley Parkway, Suite 410 Morrisville, NC 27560 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-02-24 |
| Decision Date | 2021-08-06 |