Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040325
    Device Name
    PANORET, MODEL PNM 60
    Date Cleared
    2004-03-08

    (27 days)

    Product Code
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIBELL MEDICAL VISION TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PNM 60 is a diagnostic device indicated to provide digital photographs of the interior of the eye as well as the anterior segment and external part of the eye.
    Device Description
    The PNM 60 is a modification of the legally marketed Panoret 1000 A K001111 Digital Retinoscope. It is based on transcleral illumination. Its optics distinguishes the illumination path from the imaging path, thus, enables non mydriatic wide angle imaging. The Panoret viewing angle has been changed from (Panoret 1000A) 100 degrees to PNM 60 degrees
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1