The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Mevatron Kd-2.
| Device ID | K862339 |
| 510k Number | K862339 |
| Device Name: | MEVATRON KD-2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Contact | R. C Nicol |
| Correspondent | R. C Nicol SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-10-29 |