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510(k) Data Aggregation

    K Number
    K072861
    Device Name
    CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
    Manufacturer
    ACHEVE TECHNOLOGY, INC.
    Date Cleared
    2008-06-24

    (263 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACHEVE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CeeMax™ Slit Lamp (Halogen Lamp Series/LED Illumination series) is an AC powered microscope and accessories intended for the use in the examination of the anterior eye segment, from cornea, endothelium to posterior capsule. Slit Lamp which is intended for that is used to aid the diagnosis of diseases or traumas which affect the structure or properties of the eye.
    Device Description
    The CceMax™ Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 801, 802, 901, 902, 8015S, 802SS, 901SS, 902SS are similar in design, function, materials, operation, and electro-optical electro-optical performance to other conventional AC-powered slit lamp biomicroscope.
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