BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    SENSIMED TRIGGERFISH

    K Number: DEN140017 · Decision Mar 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    668

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    Basic Information

    Device Name
    SENSIMED TRIGGERFISH
    K Number
    DEN140017
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.1925
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Sensimed AG
    Date Received
    May 6, 2014
    Decision Date
    March 4, 2016
    Product Code
    PLZ
    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
    PLZ Ocular Pattern Recorder