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510(k) Data Aggregation

    K Number
    K023292
    Device Name
    APEX HRI DIGITAL RADIOGRAPHY SYSTEM
    Date Cleared
    2002-12-13

    (72 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRUGMAN TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Apex HRI Digital Radiography System is designed to replace standard intraoral xray film and film development chemicals used for patient diagnostics in dental practices.
    Device Description
    Digital dental Intraoral Xray sensor
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