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510(k) Data Aggregation

    K Number
    K042679
    Device Name
    IR VIEWER
    Manufacturer
    INFRARED IMAGING SYSTEMS, INC.
    Date Cleared
    2004-12-10

    (72 days)

    Product Code
    KZA
    Regulation Number
    880.6970
    Why did this record match?
    Applicant Name (Manufacturer) :

    INFRARED IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures. The IR Viewer is indicated for use in procedures for inserting a needle or catheter in superficial, peripheral vessels.
    Device Description
    The IR Viewer is a non-invasive, electronic medical device that provides visualization of patient vasculature to supplement normal, line-of-sight viewing of vascular structures.
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