BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TEMPUS AI, Inc.

    Reg #: 3013200421 · FEI: 3013200421 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    TEMPUS AI, Inc.
    Registration Number
    3013200421
    FEI Number
    3013200421
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    600 W Chicago Ave #510
    City
    Chicago
    State
    IL
    ZIP
    60654
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241868
    PMA Number
    P210011

    Owner / Operator

    Firm Name
    Tempus AI, Inc.
    Operator Number
    10088107
    Address
    600 W Chicago Ave #510
    City
    Chicago
    State
    IL
    Postal Code
    60654
    Country
    US
    Correspondent
    Elaine Katrivanos

    Products

    Device Name Product Code
    Next Generation Sequencing Based Tumor Profiling Test PZM
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP
    Reduced Ejection Fraction Machine Learning-Based Notification Software QYE
    Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software SBQ

    Proprietary Names

    xR IVD xT CDx Tempus ECG-Low EF Tempus ECG-AF

    Establishment Types

    Manufacture Medical Device