The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Stereotaxis Genesis Rmn With Navigant Workstation (nws) And Cardiodrive System.
| Device ID | K193147 |
| 510k Number | K193147 |
| Device Name: | Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M58800101100030 | K193147 | 000 |
| M58800101100010 | K193147 | 000 |
| M588020004500370 | K193147 | 000 |
| M588020004500360 | K193147 | 000 |