K233737 is an FDA 510(k) clearance for the ulricheasyINJECT Max 2M (XD 10140). 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 April 19, 2024, 149 days after receiving the submission on November 22, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K233737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2023 |
| Decision Date | April 19, 2024 |
| Days to Decision | 149 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 |