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

    SURGITEK NPT MONITOR

    K Number: K875333 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    29
    Review Days
    105

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    Basic Information

    Device Name
    SURGITEK NPT MONITOR
    K Number
    K875333
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Surgitek
    Date Received
    December 30, 1987
    Decision Date
    April 13, 1988
    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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