The following data is part of a premarket notification filed by Hofmann X-ray Of America, Inc. with the FDA for Hofmann G-s60 Single Phase X-ray Generator.
| Device ID | K851011 |
| 510k Number | K851011 |
| Device Name: | HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | HOFMANN X-RAY OF AMERICA, INC. 16540 ASTON ST. Irvine, CA 92714 -4805 |
| Contact | Alex Azad |
| Correspondent | Alex Azad HOFMANN X-RAY OF AMERICA, INC. 16540 ASTON ST. Irvine, CA 92714 -4805 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-04-10 |