The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Niobe Magnetic Navigation System W/navigant Workstation.
| Device ID | K060967 |
| 510k Number | K060967 |
| Device Name: | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION |
| Classification | System, Catheter Or Guidewire, Steerable (magnetic) |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Product Code | NDQ |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-10-19 |
| Summary: | summary |