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510(k) Data Aggregation

    K Number
    K062042
    Device Name
    PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
    Manufacturer
    PLETHORA SOLUTIONS
    Date Cleared
    2006-09-06

    (49 days)

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

    PLETHORA SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.
    Device Description
    The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency. The Sexual Assessment Monitor (SAM) includes the following components: SAM application software, device control box, vibrator with integral 3m lead, serial port communications cable, 0.5m sensor lead adapter, device charger.
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