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    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇺 Hungary

    NM-01/CPT neurometer (NM-01/CPT)

    K Number: K240189 · Decision Mar 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    427

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    Basic Information

    Device Name
    NM-01/CPT neurometer (NM-01/CPT)
    K Number
    K240189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mde Orvosbiológiai Kutató, Fejleszto,
    Date Received
    January 24, 2024
    Decision Date
    March 26, 2025
    Product Code
    JXE
    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
    JXE Device, Nerve Conduction Velocity Measurement

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