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510(k) Data Aggregation

    K Number
    K052929
    Device Name
    PREFTEST PROFESSIONAL SUITE
    Manufacturer
    LIMESTONE TECHNOLOGIES INC.
    Date Cleared
    2006-04-26

    (189 days)

    Product Code
    LIL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIMESTONE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile Tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.
    Device Description
    Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain gauge transducer which measure penile tumescence in millimeters. PrefTest Professional Suite™ computer software is used to store, tabulate, display and print out the acquired data from a personal computer or lap top.
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