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

    LANTOS 3D EAR SCANNER

    K Number: K121326 · Decision Jan 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    268

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    Basic Information

    Device Name
    LANTOS 3D EAR SCANNER
    K Number
    K121326
    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
    Lantos Technologies
    Date Received
    May 2, 2012
    Decision Date
    January 25, 2013
    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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