The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Siemens Mevatron Me.
| Device ID | K852907 |
| 510k Number | K852907 |
| Device Name: | SIEMENS MEVATRON ME |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Contact | Nicol |
| Correspondent | Nicol SIEMENS MEDICAL LABORATORIES, INC. 2404 N. MAIN ST. Walnut Creek, CA 94596 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-09-19 |