The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Electron Beam Option For Clinac 15 Mev.
| Device ID | K832502 |
| 510k Number | K832502 |
| Device Name: | ELECTRON BEAM OPTION FOR CLINAC 15 MEV |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-25 |
| Decision Date | 1983-09-12 |