The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for X-ray Control And Hi-voltage Generator.
| Device ID | K921875 |
| 510k Number | K921875 |
| Device Name: | X-RAY CONTROL AND HI-VOLTAGE GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Ocar Khutoryansky |
| Correspondent | Ocar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-20 |
| Decision Date | 1992-10-15 |