The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-770 X-ray Control, Model 46-404600g4.
| Device ID | K935046 |
| 510k Number | K935046 |
| Device Name: | GX-770 X-RAY CONTROL, MODEL 46-404600G4 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | GENDEX CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-02-18 |