BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    VisioFocus Mini, VisioFocus Smart

    K Number: K160680 · Decision Apr 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    405

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    Basic Information

    Device Name
    VisioFocus Mini, VisioFocus Smart
    K Number
    K160680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tecnimed S.R.L.
    Date Received
    March 10, 2016
    Decision Date
    April 19, 2017
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Tecnimed S.R.L.

    K Number Device Name
    DEN130019 ZANZA-CLICK
    K122412 VISIOFOCUS
    K072108 MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
    K033790 THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES