FDA Registration
Active
🇺🇸 United States
Odyssey Workstation
Reg #: 3003084417
·
FEI: 3003084417
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STEREOTAXIS, INC.
- Registration Number
- 3003084417
- FEI Number
- 3003084417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 710 N. Tucker Blvd., Suite 110
- City
- Saint Louis
- State
- MO
- ZIP
- 63101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093092
Owner / Operator
- Firm Name
- Stereotaxis
- Operator Number
- 9048165
- Address
- 710 N. Tucker Blvd., Suite 110
- City
- Saint Louis
- State
- MO
- Postal Code
- 63101
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2018-12-14 |
Proprietary Names
Odyssey Workstation
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility