BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERITRON

    K Number: K945611 · Decision Feb 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    450

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    Basic Information

    Device Name
    PERITRON
    K Number
    K945611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardio Design Pty. , Ltd.
    Date Received
    November 15, 1994
    Decision Date
    February 8, 1996
    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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    Other Clearances by Cardio Design Pty. , Ltd.

    K Number Device Name
    K983052 PERITRON PERINEOMETER MODEL 9300V OR 9300A