K233549 is an FDA 510(k) clearance for the Tempus ECG-AF. This device is classified as a Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software (Class II - Special Controls, product code SBQ).
Submitted by Tempus AI, Inc. (Chicago, US). The FDA issued a Cleared decision on June 21, 2024, 231 days after receiving the submission on November 3, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation For Further Referral Or Diagnostic Follow-up..
| 510(k) Number | K233549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SBQ - Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| Definition | Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation For Further Referral Or Diagnostic Follow-up. |