The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Clinac 1800.
Device ID | K832503 |
510k Number | K832503 |
Device Name: | CLINAC 1800 |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN ASSOC., INC. 2700 MITCHELL DR. Walnut Creek, CA 94598 |
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 |