The following data is part of a premarket notification filed by Pausch Medical Gmbh with the FDA for Uroview Fd Ii.
| Device ID | K180651 |
| 510k Number | K180651 |
| Device Name: | Uroview FD II |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Pausch Medical GmbH Graf-Zeppelin-StraBe 1 Erlangen, DE D-91056 |
| Contact | Christian Stoian |
| Correspondent | Oliver Eikenberg Emergo Global Consulting LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-04-12 |
| Summary: | summary |