BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Nurochek-Pro System

    K Number: K243426 · Decision Mar 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    143

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    Basic Information

    Device Name
    Nurochek-Pro System
    K Number
    K243426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1450
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Headsafe Mfg Pty, Ltd.
    Date Received
    November 4, 2024
    Decision Date
    March 27, 2025
    Product Code
    PIW
    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
    PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

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    Other Clearances by Headsafe Mfg Pty, Ltd.

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