FDA Product Code
FDA Product Code SBQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2380
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254297 | Tempus ECG-MR | Tempus AI, Inc. | 2026-09-25 | Traditional | PDF ↗ |
| K233549 | Tempus ECG-AF | Tempus AI, Inc. | 2024-06-21 | Traditional | PDF ↗ |
Product code SBQ · Class II · Cardiovascular. Data: openFDA.