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

    PENILE ERECTION MONITOR

    K Number: K810944 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    PENILE ERECTION MONITOR
    K Number
    K810944
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Medical Monitoring Systems, Inc.
    Date Received
    April 7, 1981
    Decision Date
    April 23, 1981
    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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    Other Clearances by Medical Monitoring Systems, Inc.

    K Number Device Name
    K841879 LFT - 212