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510(k) Data Aggregation

    K Number
    K131719
    Device Name
    OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
    Manufacturer
    MEDICAL DEVICES (PVT) LTD.
    Date Cleared
    2013-10-30

    (140 days)

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

    MEDICAL DEVICES (PVT) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.
    Device Description
    The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.
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