Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri
Catheter Remote Control System
Stereotaxis, Inc.
The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Niobe® Magnetic Navigation System (mns) With Navigant Workstation (nws) And Cardiodri.
Pre-market Notification Details
| Device ID | K192775 |
| 510k Number | K192775 |
| Device Name: | Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri |
| Classification | Catheter Remote Control System |
| Applicant | Stereotaxis, Inc. 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 |
| Contact | Kenneth H. Lock |
| Correspondent | Kenneth H. Lock Stereotaxis, Inc. 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 |
| Product Code | PJB |
| CFR Regulation Number | 870.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-10-30 |
| Summary: | summary |
Trademark Results [Niobe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIOBE 88293364 not registered Live/Pending |
Jones, Sebastian A. 2019-02-07 |
 NIOBE 75816410 2779812 Live/Registered |
Stereotaxis, Inc. 1999-10-05 |
 NIOBE 74504133 not registered Dead/Abandoned |
Adaptec, Inc. 1994-03-22 |
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