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

    MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

    K Number: K033126 · Decision Oct 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
    K Number
    K033126
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behavioral Technology, Inc.
    Date Received
    September 30, 2003
    Decision Date
    October 29, 2003
    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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