The following data is part of a premarket notification filed by Vf-works, Inc. with the FDA for Visualizer 2000.
| Device ID | K943272 |
| 510k Number | K943272 |
| Device Name: | VISUALIZER 2000 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | VF-WORKS, INC. 973 VIRGINIA AVENUE SUITE 11 Palm Harbor, FL 34683 |
| Contact | John R Postlethwaite |
| Correspondent | John R Postlethwaite VF-WORKS, INC. 973 VIRGINIA AVENUE SUITE 11 Palm Harbor, FL 34683 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-12-27 |