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

    VISER PENILE TUMESCENCE MONITOR

    K Number: K991479 · Decision Jul 7, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    VISER PENILE TUMESCENCE MONITOR
    K Number
    K991479
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laborie Medical Tech Corp.
    Date Received
    April 28, 1999
    Decision Date
    July 7, 1999
    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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