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

    Bullsai Confirm

    K Number: K243520 · Decision Mar 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    135

    Basic Information

    Device Name
    Bullsai Confirm
    K Number
    K243520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Turing Medical Technologies, Inc.
    Date Received
    November 13, 2024
    Decision Date
    March 28, 2025
    Product Code
    QQC
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QQC Brain Stimulation Programming Planning Software.

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