SIMULIX EVOLUTION
System, Simulation, Radiation Therapy
NUCLETRON CORPORATION
The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Simulix Evolution.
Pre-market Notification Details
| Device ID | K033470 |
| 510k Number | K033470 |
| Device Name: | SIMULIX EVOLUTION |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. P.O. BOX 5185 6802 ED ARNHEM Arnhem, NL |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-03 |
| Decision Date | 2004-02-04 |
| Summary: | summary |
Trademark Results [SIMULIX EVOLUTION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMULIX EVOLUTION 78313328 3007256 Dead/Cancelled |
Nucletron B.V. 2003-10-14 |
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