The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Odyssey Workstation.
| Device ID | K072371 |
| 510k Number | K072371 |
| Device Name: | ODYSSEY WORKSTATION |
| Classification | System, Catheter Control, Steerable |
| 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 | DXX |
| CFR Regulation Number | 870.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-23 |
| Decision Date | 2007-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M58800100701020 | K072371 | 000 |