BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    SMARTO

    K Number: K101563 · Decision Dec 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    28
    Applicant Total
    53
    Review Days
    196

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    Basic Information

    Device Name
    SMARTO
    K Number
    K101563
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jeil Medical Corporation
    Date Received
    June 4, 2010
    Decision Date
    December 17, 2010
    Product Code
    KIJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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