LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033126
    Device Name
    MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
    Manufacturer
    BEHAVIORAL TECHNOLOGY, INC.
    Date Cleared
    2003-10-29

    (29 days)

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

    BEHAVIORAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
    Device Description
    MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.
    Ask a Question

    Page 1 of 1