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

    CONTACT LENS OPHTHALMODYNAMOMETER

    K Number: K052674 · Decision May 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    239

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    Basic Information

    Device Name
    CONTACT LENS OPHTHALMODYNAMOMETER
    K Number
    K052674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditron, GmbH
    Date Received
    September 27, 2005
    Decision Date
    May 24, 2006
    Product Code
    NYK
    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
    NYK Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)