BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Tempus ECG-AF

    K Number: K233549 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    231

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Tempus ECG-AF
    K Number
    K233549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tempus AI, Inc.
    Date Received
    November 3, 2023
    Decision Date
    June 21, 2024
    Product Code
    SBQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

    Other Clearances by Tempus AI, Inc.

    K Number Device Name
    K241868 xR IVD
    K250119 Tempus ECG-Low EF