The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Navigant Magnetic Navigation Workstation 2.1 (nws2) Model, 020-004500.
| Device ID | K032937 |
| 510k Number | K032937 |
| Device Name: | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 |
| Classification | System, Catheter Control, Steerable |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Peter A Takes |
| Correspondent | Peter A Takes STEREOTAXIS, INC. 4041 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2004-07-01 |
| Summary: | summary |