BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100

    K Number: K152644 · Decision Dec 31, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
    K Number
    K152644
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keeler Limited
    Date Received
    September 16, 2015
    Decision Date
    December 31, 2015
    Product Code
    HKY
    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
    HKY Tonometer, Manual

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