The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Siemens Polydoros 800.
| Device ID | K820112 |
| 510k Number | K820112 |
| Device Name: | SIEMENS POLYDOROS 800 |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-15 |
| Decision Date | 1982-02-24 |