510(k) K254297
- Device
- Tempus ECG-MR
- Applicant
- Tempus AI, Inc.
- 510(k) number
- K254297
- Product code
- SBQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-25
- Date received
- 2025-12-31
- Regulation
- 870.2380
- Classification name
- Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bethany Barrett
- Address
- 600 W Chicago Ave. Suite #510 Chicago IL US 60654 60654
FDA Registration Numbers#
- 3013200421
Source Documents#
Other 510(k) Records For Product Code SBQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233549 | Tempus ECG-AF | Tempus AI, Inc. | 2024-06-21 |