The following data is part of a premarket notification filed by Pausch Medical Gmbh with the FDA for Uroview Fd.
| Device ID | K161019 |
| 510k Number | K161019 |
| Device Name: | Uroview FD |
| 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 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-12 |
| Decision Date | 2016-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260491620057 | K161019 | 000 |
| 04260491620033 | K161019 | 000 |
| 04260491620019 | K161019 | 000 |
| 04260491620002 | K161019 | 000 |