510(k) K193147 ยท PJB Catheter Remote Control System
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
| Applicant | Stereotaxis, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 5, 2020 |
| Received | Nov 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193147
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.