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    K Number
    K131939
    Device Name
    AMICO DH-W35 OPHTHALMOSCOPE SERIES
    Manufacturer
    AMICO DIAGNOSTIC INCORPORATED
    Date Cleared
    2014-03-26

    (272 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMICO DIAGNOSTIC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
    Device Description
    The ophthalmoscope is an AC powered hand-held device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.
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