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510(k) Data Aggregation

    K Number
    K100954
    Device Name
    ADAPT, MODEL AX-03SN
    Manufacturer
    APELIOTUS VISION SCIENCE, INC
    Date Cleared
    2011-02-25

    (324 days)

    Product Code
    OUM
    Regulation Number
    886.1050
    Why did this record match?
    Product Code :

    OUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Adapt™ is an AC powered, automated adaptometer (biophotometer), intended to measure the time for retinal adaptation after exposure to an adapting light.
    Device Description
    The AdaptTM is an AC-powered, automated, adaptometer (biophotometer).
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