The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Mevatron 74x Medical Linear Accelerator.
Device ID | K791967 |
510k Number | K791967 |
Device Name: | MEVATRON 74X MEDICAL LINEAR ACCELERATOR |
Classification | Accelerator, Linear, Medical |
Applicant | SIEMENS MEDICAL LABORATORIES, 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 | 1979-10-02 |
Decision Date | 1979-11-16 |