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

    MAKLAKOV STYLE TONOMETER

    K Number: K860330 · Decision Feb 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    MAKLAKOV STYLE TONOMETER
    K Number
    K860330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Med-Tech Develoment Corp.
    Date Received
    January 29, 1986
    Decision Date
    February 12, 1986
    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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