BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR

    K Number: DEN130022 · Decision Dec 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    283

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    Basic Information

    Device Name
    NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
    K Number
    DEN130022
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5808
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Eneura Therapeutics
    Date Received
    March 5, 2013
    Decision Date
    December 13, 2013
    Product Code
    OKP
    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
    OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

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