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

    INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE

    K Number: K133013 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
    K Number
    K133013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inventis S.R.L.
    Date Received
    September 25, 2013
    Decision Date
    January 24, 2014
    Product Code
    ETY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETY Tester, Auditory Impedance

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