DeviceClearance

Product code SBQ— Cardiovascular

Tempus ECG-AF

Classification name
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SBQ under 21 CFR 870.2380, via openFDA

Market context for product code SBQ

FDA has cleared 2 devices under product code SBQ between 2024 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SBQ

Recent clearances under product code SBQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.