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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    ARGOS

    K Number: K150754 · Decision Oct 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    193

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    Basic Information

    Device Name
    ARGOS
    K Number
    K150754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Santec Corporation
    Date Received
    March 23, 2015
    Decision Date
    October 2, 2015
    Product Code
    MXK
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MXK Device, Analysis, Anterior Segment

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    Other Clearances by Santec Corporation

    K Number Device Name
    K191051 ARGOS