SBQ — Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software Class II
FDA product code SBQ covers "Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software", a Class II medical device regulated under 21 CFR 870.2380. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBQ
- Device Class
- Class II
- Regulation Number
- 870.2380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233549 | tempus ai | Tempus ECG-AF | June 21, 2024 |