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

    NOCTURNAL PENILE TUMESCENCE MONITOR

    K Number: K870983 · Decision Jun 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    NOCTURNAL PENILE TUMESCENCE MONITOR
    K Number
    K870983
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Texas Medical Electronics Co.
    Date Received
    March 10, 1987
    Decision Date
    June 23, 1987
    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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