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

    Relivion

    K Number: K212106 · Decision Aug 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    Relivion
    K Number
    K212106
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5891
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurolief , Ltd.
    Date Received
    July 6, 2021
    Decision Date
    August 2, 2021
    Product Code
    PCC
    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
    PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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