BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)

    K Number: K062042 · Decision Sep 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    49

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    Basic Information

    Device Name
    PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
    K Number
    K062042
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plethora Solutions
    Date Received
    July 19, 2006
    Decision Date
    September 6, 2006
    Product Code
    LIL
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIL Monitor, Penile Tumescence

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