The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Rms-2000.
| Device ID | K863358 |
| 510k Number | K863358 |
| Device Name: | VARIAN RMS-2000 |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Contact | Milton D Siegel |
| Correspondent | Milton D Siegel VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-29 |
| Decision Date | 1986-09-19 |