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

    EVRF SYSTEM

    K Number: K130283 · Decision Mar 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    EVRF SYSTEM
    K Number
    K130283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    F Care Systems NV
    Date Received
    February 5, 2013
    Decision Date
    March 7, 2013
    Product Code
    ONQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONQ Electrosurgical Coagulation For Aesthetic

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