BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇱 Poland

    SACCADOMETER PLUS, SACCADOMETER ADVANCED

    K Number: K152890 · Decision Aug 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    316

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    Basic Information

    Device Name
    SACCADOMETER PLUS, SACCADOMETER ADVANCED
    K Number
    K152890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1510
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ober Consulting Sp. Z.O.O.
    Date Received
    September 30, 2015
    Decision Date
    August 11, 2016
    Product Code
    HLL
    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
    HLL Monitor, Eye Movement

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