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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    I RUNE (I-200L)

    K Number: K122410 · Decision Nov 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    1
    Review Days
    461

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    Basic Information

    Device Name
    I RUNE (I-200L)
    K Number
    K122410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medirune Co, Ltd.
    Date Received
    August 8, 2012
    Decision Date
    November 12, 2013
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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