The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Ulrichinject Ct Motion.
| Device ID | K171392 |
| 510k Number | K171392 |
| 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. PO Box 110352 Durham, NC 27709 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-05-11 |
| Decision Date | 2017-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052536184514 | K171392 | 000 |
| 04052536181216 | K171392 | 000 |
| 04052536180424 | K171392 | 000 |
| 04052536180400 | K171392 | 000 |
| 04052536179923 | K171392 | 000 |
| 04052536002245 | K171392 | 000 |