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

    OTODYNAMICS OTOPORT

    K Number: K072033 · Decision Nov 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    7
    Review Days
    112

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    Basic Information

    Device Name
    OTODYNAMICS OTOPORT
    K Number
    K072033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otodynamics, Ltd.
    Date Received
    July 24, 2007
    Decision Date
    November 13, 2007
    Product Code
    EWO
    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
    EWO Audiometer

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    Other Clearances by Otodynamics, Ltd.

    K Number Device Name
    K240430 Otoport Pro
    K143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
    K983350 ILO292 DP ECHOPORT PLUS OAE SYSTEM
    K983352 ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
    K983351 ILO292 DP ECHOPORT PLUS OAE SYSTEM
    K962995 ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC