BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Delphi Amplifier

    K Number: K243746 · Decision Mar 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    Delphi Amplifier
    K Number
    K243746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantalx Neroscience
    Date Received
    December 5, 2024
    Decision Date
    March 12, 2025
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

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