The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for X-ray Stand & Operating Chair.
| Device ID | K803162 |
| 510k Number | K803162 |
| Device Name: | X-RAY STAND & OPERATING CHAIR |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | DOWNS SURGICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1981-01-28 |