BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OSRAM ITOS

    K Number: K110326 · Decision Oct 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    OSRAM ITOS
    K Number
    K110326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osram Sylvania, Inc.
    Date Received
    February 3, 2011
    Decision Date
    October 27, 2011
    Product Code
    ERA
    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
    ERA Otoscope

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