BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PERIFORM PERINEOMETRIC PROBE, MODEL 8300

    K Number: K002617 · Decision Apr 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    225

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    Basic Information

    Device Name
    PERIFORM PERINEOMETRIC PROBE, MODEL 8300
    K Number
    K002617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neen Design , Ltd.
    Date Received
    August 23, 2000
    Decision Date
    April 5, 2001
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    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
    HIR Perineometer

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