510(k) K233549

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

June 21, 2024

Date Received

November 3, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Device Class

Class II

Regulation Number

870.2380

Review Panel

CV

Submission Type

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.