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

    FULL AUTO TONOMETER MODEL TX-20

    K Number: K111710 · Decision Sep 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    10
    Review Days
    92

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    Basic Information

    Device Name
    FULL AUTO TONOMETER MODEL TX-20
    K Number
    K111710
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canon Inc. -Medical Equipment Group
    Date Received
    June 20, 2011
    Decision Date
    September 20, 2011
    Product Code
    HKX
    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
    HKX Tonometer, Ac-Powered

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