BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    Delphi-MD System

    K Number: DEN250002 · Decision Aug 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    229

    Basic Information

    Device Name
    Delphi-MD System
    K Number
    DEN250002
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1860
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Quantalx Neuroscience, Ltd.
    Date Received
    January 3, 2025
    Decision Date
    August 20, 2025
    Product Code
    SFN
    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
    SFN Non-Invasive Evoked Response Brain Stimulator

    Other Clearances by Quantalx Neuroscience, Ltd.

    K Number Device Name
    K243243 Delphi MCS Electrode Cap