BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇪🇸 Spain

    DIGITAL INFLECTION RIGIDOMETER (DIR)

    K Number: K000194 · Decision Apr 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    DIGITAL INFLECTION RIGIDOMETER (DIR)
    K Number
    K000194
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uroan Xxi Electromedicina
    Date Received
    January 21, 2000
    Decision Date
    April 10, 2000
    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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