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510(k) Data Aggregation

    K Number
    K031639
    Device Name
    INTERMED ZOOM COLPOSCOPE
    Manufacturer
    INTERMED GROUP, INC.
    Date Cleared
    2003-08-22

    (87 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERMED GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intermed Zoom Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.
    Device Description
    The Intermed Zoom Colposcope consists of a stereo zoom microscope mounted to a mobile floor stand. A halogen light source with an integrated green filter is also mounted to the stand providing subject illumination.
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