BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Nelli (Version 7.11)

    K Number: K251506 · Decision Nov 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    189

    Basic Information

    Device Name
    Nelli (Version 7.11)
    K Number
    K251506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1580
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro Event Labs OY
    Date Received
    May 16, 2025
    Decision Date
    November 21, 2025
    Product Code
    POS
    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
    POS Physiological Signal Based Seizure Monitoring System

    Similar 510(k) Clearances

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

    NightWatch+ US

    FDA 510(k)
    FDA Class 2 ·Neurology

    EpiMonitor

    FDA 510(k)
    FDA Class 2 ·Neurology

    EpiWatch Monitoring System

    FDA 510(k)
    FDA Class 2 ·Neurology

    EpiMonitor

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPEAC System

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPEAC System

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