FDA Registration
Active
🇺🇸 United States
Tempus ECG-AF
Reg #: 3013200421
·
FEI: 3013200421
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TEMPUS AI, Inc.
- Registration Number
- 3013200421
- FEI Number
- 3013200421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 600 W Chicago Ave #510
- City
- Chicago
- State
- IL
- ZIP
- 60654
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233549
Owner / Operator
- Firm Name
- Tempus AI, Inc.
- Operator Number
- 10088107
- Address
- 600 W Chicago Ave #510
- City
- Chicago
- State
- IL
- Postal Code
- 60654
- Country
- US
- Correspondent
- Elaine Katrivanos
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | SBQ | Class 2 | Cardiovascular | No | 2024-08-08 |
Proprietary Names
Tempus ECG-AF
Establishment Types
Manufacture Medical Device