BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC

    K Number: K962995 · Decision Jan 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    234
    Applicant Total
    6
    Review Days
    162

    Basic Information

    Device Name
    ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
    K Number
    K962995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OTODYNAMICS, LTD.
    Date Received
    August 1, 1996
    Decision Date
    January 10, 1997
    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
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