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

    XCEL 455 SLIT LAMP

    K Number: K141954 · Decision Oct 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    XCEL 455 SLIT LAMP
    K Number
    K141954
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reichert, Inc.
    Date Received
    July 18, 2014
    Decision Date
    October 15, 2014
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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