510(k) K192775 · PJB Catheter Remote Control System
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
| Applicant | Stereotaxis, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Oct 30, 2019 |
| Received | Sep 30, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Stereotaxis Inc Niobe ES System, Models 001-006000-1 and 001-006100-1 Terminated |
PJB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.