The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Urological C-arm Table, Model #056-450.
| Device ID | K922591 |
| 510k Number | K922591 |
| Device Name: | UROLOGICAL C-ARM TABLE, MODEL #056-450 |
| Classification | Table, Radiographic, Tilting |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Contact | Clyde Schein |
| Correspondent | Clyde Schein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1992-11-27 |