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

    TONO-PEN TONOMETER TIP COVER

    K Number: K033146 · Decision Nov 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    420

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    Basic Information

    Device Name
    TONO-PEN TONOMETER TIP COVER
    K Number
    K033146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tra & Accessories
    Date Received
    September 30, 2003
    Decision Date
    November 23, 2004
    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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