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

    LEICA AT550

    K Number: K990869 · Decision Jun 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    40
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    83

    Basic Information

    Device Name
    LEICA AT550
    K Number
    K990869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LEICA MICROSYSTEMS, INC.
    Date Received
    March 16, 1999
    Decision Date
    June 7, 1999
    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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