The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Odyssey Workstation.
| Device ID | K093092 |
| 510k Number | K093092 |
| Device Name: | ODYSSEY WORKSTATION |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 St. Louis, MO 63108 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-01-21 |
| Summary: | summary |