The following data is part of a premarket notification filed by General Electric Co. with the FDA for Mpg 65-80-100 X-ray Generator And Control.
| Device ID | K921951 |
| 510k Number | K921951 |
| Device Name: | MPG 65-80-100 X-RAY GENERATOR AND CONTROL |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1992-07-21 |