The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Deluxe C Arm Radiological Table, Model #056-004.
| Device ID | K921501 |
| 510k Number | K921501 |
| Device Name: | DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 |
| Classification | Table, Radiographic, Non-tilting, Powered |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Product Code | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-05-15 |