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

    RT2 RIGIDITY AND TUMESCENCE TEST

    K Number: K925931 · Decision Dec 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    RT2 RIGIDITY AND TUMESCENCE TEST
    K Number
    K925931
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Compass Medical Technologies, Inc.
    Date Received
    November 23, 1992
    Decision Date
    December 21, 1992
    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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