The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Tecnomed Generator, Radiograph., 3 Phase.
| Device ID | K820307 |
| 510k Number | K820307 |
| Device Name: | TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | TECNOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-04 |
| Decision Date | 1982-03-05 |