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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

    K Number: K946337 · Decision Dec 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    20
    Review Days
    356

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    Basic Information

    Device Name
    IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
    K Number
    K946337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    December 29, 1994
    Decision Date
    December 20, 1995
    Product Code
    EGJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EGJ Device, Iontophoresis, Other Uses

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