The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for Uroview 2000, Modification.
| Device ID | K914446 |
| 510k Number | K914446 |
| Device Name: | UROVIEW 2000, MODIFICATION |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | John W Tolhurst |
| Correspondent | John W Tolhurst OEC-DIASONICS, INC. 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 | 1991-10-04 |
| Decision Date | 1992-01-10 |