BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EER ERECTION ENHANCED RESPONDER

    K Number: K904406 · Decision Feb 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    154

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    Basic Information

    Device Name
    EER ERECTION ENHANCED RESPONDER
    K Number
    K904406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Eer, Inc.
    Date Received
    September 24, 1990
    Decision Date
    February 25, 1991
    Product Code
    LKY
    Advisory Committee
    Gastroenterology, Urology
    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
    LKY Device, External Penile Rigidity

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