The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Uroview Model 2600.
| Device ID | K940295 |
| 510k Number | K940295 |
| Device Name: | UROVIEW MODEL 2600 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Thomas R Meyers |
| Correspondent | Thomas R Meyers GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-08-22 |