The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Telstar Magnetic Navigation Systems [mns}, Telstar Bi-plane Digital Imaging System, Niobe Electrophysiology Mapping Cath.
| Device ID | K013484 |
| 510k Number | K013484 |
| Device Name: | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | STEREOTAXIS, INC. 4041 FOREST PARK BLVD. St. Louis, MO 63108 |
| Contact | Peter A Takes |
| Correspondent | Peter A Takes STEREOTAXIS, INC. 4041 FOREST PARK BLVD. St. Louis, MO 63108 |
| Product Code | DRF |
| Subsequent Product Code | DXX |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2002-05-02 |
| Summary: | summary |