The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Navigant Workstation With Niobe Magnetic Navigation System, Model Nws05.
| Device ID | K051760 |
| 510k Number | K051760 |
| Device Name: | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 |
| Classification | System, Catheter Control, Steerable |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Peter A Takes |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2006-05-05 |
| Summary: | summary |