BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    iSyncBrain©-C

    K Number: K222838 · Decision Mar 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    177

    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
    iSyncBrain©-C
    K Number
    K222838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    iMediSync, Inc.
    Date Received
    September 20, 2022
    Decision Date
    March 16, 2023
    Product Code
    OLU
    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
    OLU Normalizing Quantitative Electroencephalograph Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OLU), ordered by most recent decision date.

    Cognitive Function Neuroimaging (cfNI) Software (1.0.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroField Analysis Suite

    FDA 510(k)
    FDA Class 2 ·Neurology

    BrainView QEEG Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    BNA Platform

    FDA 510(k)
    FDA Class 2 ·Neurology

    cortiQ PRO

    FDA 510(k)
    FDA Class 2 ·Neurology

    qEEG-Pro

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by iMediSync, Inc.

    K Number Device Name
    K220056 iSyncWave